[Summary text]
Study design:
Study grouping:
Baseline Characteristics
Intervention 1 (RCW)
Intervention 2 (Half-Shoe)
Kontrol 1 (TCC)
Included criteria: The diag-nosis of diabetes had been made before enrollment and was confirmed either by communication with primary care providers or by reviewing medical records. All patients had clinically significant loss of protective sensation (.25 V) as measured with a biothesiometer (BiomedicalInstrument, Newbury, OH) (18,19), at least one palpable foot pulse or a transcutaneous oximetry (TcPO2) measurement higher than 40 mmHg at the level of the dorsum of the forefoot, and a neuropathic plantar diabetic foot ulcer corresponding to grade 1A (superficial, not extending totendon, capsule, or bone using the University of Texas Diabetic Foot Wound Classification System) (20). Neuropathy was defined as the inability to sense the 10-g Semmes-Weinstein monofilament and a vibration perception threshold.25 V (18,19,21). If patients had more than one plantar wound, the largest wound was used as the index ulcerfor inclusion in this study.
Excluded criteria: Patients who had ac-tive infection, were unable to walk with-out wheelchair assistance, had wounds in locations on the heel, rear foot, or area other than the plantar aspect of the foot,or had severe peripheral vascular disease (diagnosed by the criteria listed above) were excluded from the study.
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: This study was fundedby the U.S. Department of Veterans Affairs’Rehabilitation R&D Merit Award GrantA2150RC and the Aircast Research Founda-tion.
Country: USA
Setting: 63 patientswith superficial noninfected, nonischemic diabetic plantar foot ulcers were randomized to one ofthree off-loading modalities: TCC, half-shoe, or RCW
Authors name: David G. Armstrong
Institution: Department of Surgery, SouthernArizona Veterans Affairs Medical Center
Email: armstrong@usa.net
Address: Department of Surgery, SouthernArizona Veterans Affairs Medical Center, 3601 South Sixth Ave., Tucson, AZ 85723.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Overall
Included criteria: All patients had experienced the loss of protective sensation (25 V) as measured with a vibration perception threshold meter (Xilas, SanAntonio, TX) (12,13), at least one palpable foot pulse, and a neuropathic plantardiabetic foot ulcer corresponding to grade 1A (superficial, not extending to tendon,capsule, or bone, according to the Univer-sity of Texas Diabetic Foot Wound Classification System) (14,15). Wound size was evaluated by measuring the maximum length by the maximum width. If patients had more than one plantar wound, the largest wound was used as the index ulcer for inclusion in this study.
Excluded criteria: Patients with active infection; unable towalk without a wheelchair; with wounds in locations on the heel, rearfoot, or a location other than the plantar aspect of thefoot; or with severe peripheral vasculardisease (diagnosed by the criteria listed above based on the absence of both footpulses on the affected extremity) were excluded.
Pretreatment: wound size was nearly greater in the iTCC group (2.71.3 vs.2.01.1 cm2,P0.07)
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: This work was sup-ported by U.S. Department of Veterans Affairs,Health Services Research and DevelopmentAward IIR 20-059 and the Rehabilitation Re-search and Development Merit AwardA2150RC.
Country: USA
Setting: randomly assigned 50 patients withUniversity of Texas grade 1A diabetic foot ulcerations into one of two off-loading treatmentgroups: an RCW or the same RCW wrapped with a cohesive bandage (iTCC)
Authors name: DAVID G. ARMSTRONG
Institution: Center for Lower Extremity Ambulatory Research, the Dr. William M. Scholl College of PodiatricMedicine at Rosalind Franklin University of Medicine, Chicago, Illinois
Email: E-mail: armstrong@usa.net
Address: Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science, 3333 GreenBay Rd., North Chicago, IL 60064
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: diabetic patients with neuropathic plantarulcers. All the subjects were insensitive toSemmes-Weinstein 5.07 monofilament andhad a vibration perception threshold of 25 V,measured on the malleolus with a biothe-siometer (Neurothesiometer; S.L.S., Notting-ham, U.K.).
Excluded criteria: The exclusion criteria were theclinical presence of deep or superficial tissueinfection or underlying osteomyelitis (boneexposure or X-ray of the foot), transcuta-neous PO2(30 mmHg and/or ankle-brachialindex [ABI] of 0.6), severe problems inmaintaining equilibrium, severe visualdeficit, skin lesions of the foot (other than the ulcer under study) or leg, amputation ofa limb, or plantar bilateral ulcerations.
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: no funding
Country: Italy
Setting: Fifty diabetic patients with neuropathicplantar ulcers were consecutively enrolled and randomized to one of two treatment groups. Ofthe 50 patients, 24 were treated with a specialized cloth shoe with a rigid sole and an unload-ing alkaform insole (shoe group), and 26 patients were treated with a nonremovable off-bear-ing fiberglass cast (cast group
Authors name: Carlo Caravaggi,
Institution: the Center for the Study and Treatment of Diabetic Foot Pathology, Ospedale di Abbiategrasso (C.C.,R.D.G., E.S., C.P.); Internal Medicine Unit (E.F., M.M., A.Q., M.G.), Policlinico Multimedica, Sesto S. Gio-vanni (Milan); and the Institute of Medical Stat
Email: cara@mail3.telnetwork.it
Address: Centro per la Cura e lo Studio delPiede Diabetico, Pz Mussi 1, Abbiategrasso (Milano) 20080, Italy.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: All participants had peripheral neu-ropathy, as highlighted by insensitivity to10 g monofilament and vibration percep-tion threshold measured by biothesiom-eter at malleolus of at least 25 volts, andpresented with a neuropathic ulcer on thewhole part of the plantar surface of thefoot, including ulcers correlated withCharcot neuroarthropathy deformities
Excluded criteria: We excluded patients with superficialtissue infection, osteomyelitis, TcPO2(transcutaneous PO2)30 mmHg, anklebrachial index0.6, severe visual deficit,severe problems of equilibrium, amputa-tion of the controlateral limb, and bilat-eral plantar ulcers.
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: no funding
Country: italy
Setting: 60 consecutive dia-betic patients with neuropathic plantarulcers were seen and randomly assignedto two groups: group A, using an AircastPneumatic Walker (XP Diabetic Walker);and group B, using the fiberglass off-loading cast
Authors name: CARLO CARAVAGGI
Institution: Department of Diabetic Foot Pathology, Ospedale di Abbiategrasso, Milan, Italy
Email: carlo.caravaggi@fastwebnet.it.
Address: Ospedale di Abbiategrasso, DiabeticFoot Pathology, Pz Mussi 1, Abbiategrasso (Milano) 20080, Italy.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: To be eligible for the study, participants should be ambulatory, have solitary neuropathic plantar ulcer grade 1A or 2A using the University of Texas scale, and unilateral foot involvement. The grade was based on clinical examina-tion and evaluation of a plain digital radiograph
Excluded criteria: Patients unable to walk indoors, with significant comorbidities, infected ulcers and/or osteomyelitis, ankle brachial index (ABI) < 0.9, and Charcot osteoarthropathy were excluded.
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: no funding
Country: india
Setting: Thirty adult diabetic patients attending the foot clinic with neuropathic plantar ulcers irrespective of sex, age, duration and type of diabetes were randomly assigned to 1 of 2 off-loading modalities (TCC and PRAFO
Authors name: Partha Pratim Chakraborty
Institution: Department of Endocrinology and Metabolism,
Email: sayantan.ray30@gmail.com
Address: Institute of Post Graduate Medical Education & Research (IPGMER) and SSKM Hospital, Kolkata, West Bengal, India
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Study inclusion criteria were the presence of a neuropathic plantar forefoot ulcer with an area graded IA according to the University of Texas Classification of Dia-betic Wounds (11). Peripheral neuropa-thy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofila-ment in more than six of nine areas of the foot and by a vibration perception thresh-old measured by biothesiometer (Neu-rothesiometer SLS, Nottingham, U.K.) at the malleolus of 25 V.
Excluded criteria: Exclusion criteria were the presence of an ankle-brachialpressure index 0.9 and/or transcutane-ous oxygen tension 50 mmHg tested on the dorsum of the foot and clinical signs of infection. Both the probe-to-bone maneuver and standard X-ray examination of the foot were required to be negative for osteomyelitis (12). Additional exclusion criteria included use of steroids or antimitotic drugs, the presence of visualproblems that could impair balance, anactive ulcer on the contralateral foot, previous major amputation of the contralateral limb, previous or current deep venous thrombosis of the leg, or mental disorder interfering with patient compliance.
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: We acknowledge thecontribution of Podartis, Montebelluna, Tre-viso, Italy, manufacturers of the Stabil-D walk-ers used in this study
Country: italy
Setting: Forty-five adult diabetic patients with non-ischemic, noninfected neuropathic plantar ulcer were randomly assigned for treatment with anonremovable fiberglass off-bearing cast (total contact cast [TCC] group) or walker cast (Stabil-Dgroup).
Authors name: EZIO FAGLIA
Institution: diabetic foot center, Milan
Email: iacomo.clerici@multimedica.it.
Address: Diabetic Foot Center, Istituto di Ricovero e Cura a Carattere Scientifico Multimedica, Sesto SanGiovanni, Milan, Italy
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: pt with DFU
Excluded criteria: osteomyelitis and any other contraindication of total contact casting
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: no funding
Country: india
Setting: Total contact casting is one such method of offloading, and this study attempts to investigate the advantages of the above method as compared to conventional dressings in the physiatric management of the depth--ischaemia grades 1A, 1B, 2A, 2B neuropathic plantar ulcers in a diabetic patient.
Authors name: Ganguly S
Institution: Department of physical medicine and rehabilitation, institute of postgraduate mediacal education and research, kolkata
Email: no email
Address: Department of physical medicine and rehabilitation, institute of postgraduate mediacal education and research, kolkata, 700020
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Diabetic patients with grade UT1A or UT2A forefoot ulcers(the University of Texas Ulcer Classification System) (18) onthe sole of the foot were enrolled. If more than one ulcer waspresent, the largest ulcer meeting all the eligibility criteria wasselected as the index ulcer. Other ulcers were treated in thesame manner as the study ulcer.
Excluded criteria: Patients were excluded based on the following criteria: inability to care for their ulcer during the study period (e.g. because of vacation, hospitalisation anddisability), widespread malignancy, systematically immune-compromising disease, severe peripheral vascular disease (ABI < 0·60 or transcutaneous oxygen < 25 mm/Hg), alcoholor substance abuse within 6 months, untreated osteomyelitisor Charcot arthropathy with residual deformity that was too severe to allow proper fit of the removable walking boot,and patients with postural stability that was not adequateto safely ambulate in a TCC or walking boot.
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: a grant from the national institute of health
Country: usa
Setting: 12 week singleblinded rct consisting of 73 pt divided in three groups. TCC vs walker vs sandals
Authors name: Lawrence a lavery
Institution: Department of surgery, university of texas
Email: larry.lavery@utsouthwestern.edu
Address: University of texas southwestern medical center
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Criteria for inclusion in the study were that the patienthad been diagnosed with diabetes mellitus and currently had a plantar ulcer
Excluded criteria: No evidence of gross infection (no significant edema or drainage), osteomyelitis (deter-mined by radiograph or radionuclide scans), or gan-grene (visibly discolored or necrotic tissue).
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: This study was supported by a grant from the Foun-dation for Physical Therapy.
Country: USA
Setting: Fortypatients with diabetes mellitus and a plantar ulcer butwith no gross infection, osteomyelitis, or gangrene wererandomly assigned to the TCC group (n = 21) or TDTgroup (n = 19).
Authors name: Michael |. Mueller
Institution: Irene Walter Johnson Rehabilitation Institute, Program in Physical Ther-apy, and Division of Orthopedic Surgery, Department of Surgery, WashingtonUniversity School of Medicine,st. louis, Missouri
Email: no email contact
Address: Washington University School of Medicine, Box8083, 660 South Euclid Avenue, St. Louis, MO 63110
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Forty-nine eligible subjects with confirmed diabetes and PN, age 18 or older with noninfected, non ischemic, plantar neu-ropathic foot ulcers.If subjects had noncompressible vessels (ABI > 1.2), we measured toe pressures to determine a toe brachial index (TBI). A TBI > 0.65 was required for enrollment.
Excluded criteria: Subjects with major foot amputation, active Charcot arthropathy, ankle brachial index (ABI) of 0.5 or less,27 history of alcohol or substance abuse within 6 months, or unable to keep research appointments were excluded. In addition, we excluded those patients, who could not be accommodated in a standard removable cast walker or were unable to walk a distance of minimum 20 minutes with or without an assistive device.
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: The project described was supported in part by a grant from the Qatar National Research Foundation (Award Number NPRP 4-1026-3-277, http://www.qnrf.org/). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Qatar National Research Foundation. None of the authors employed or contracted by the fund
Country: USA
Setting: Forty-nine people with diabetic foot ulcers were randomized to wear either a removable cast walker (RCW) or an irremovable instant total contact cast (iTCC).
Comments:
Authors name: Bijan Najafi
Institution: Interdisciplinary Consortium on Advanced Motion Performance (iCAMP)
Email: najafi.bijan@gmail.com
Address: Department of Surgery, Baylor College of Medicine, One Baylor Plaza, MS:BCM390, Houston, TX 77030, USA.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: type 1 or type 2 diabetes lasting for at least 5 years; presence of a forefoot plantar ulcer wider than 1 cm2, staged IA or IIA according to the University of Texas Diabetic Wound Classification,1 last-ing at least 6 weeks; ankle-brachial pressure index ≥0.9 with 2 palpable pulses in the affected foot.
Excluded criteria: Exclusion cri-teria were the presence of infection according to the crite-ria of the Infectious Disease Society of America guidelines20; surgical procedure in the previous year on the affected foot; inability to actively dorsiflex the affected foot; involvement of deeper foot structures, that is, probe-to-bone negative; presence of other lesions in the same or contralateral foot; diagnosis of acute or chronic Charcot foot, either in the affected or contralat-eral foot; lower limb edema; chronic renal insufficiency as demonstrated by creatinine >2 mg/dL; previous minor or major amputations in the affected or contralateral limb; nonambulatory; body mass index >35; visual impairment; metabolic decompensation with HbA1c >10%; cancer; HIV-positive; or any local or systemic conditions that may impair tissue repair. In cases of suspected osteomy-elitis, a radiograph of the foot and a magnetic resonance imaging was performed in order to confirm the diagnosis and justify exclusion from the study.
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: he author(s) received no financial support for the research, authorship, and/or publication of this article
Country: italy
Setting: 60 patients with DFUs, randomly assigned to 3 different offloading modalities: TCC (group A), walking boot rendered irremovable (i-RWD; group B), and removable walking boot (RWD; group C). Patients were followed up weekly for 90 days
Comments:
Authors name: Alberto Piaggesi
Institution: Sezione Dipartimentale Piede Diabetico, Dipartimento di Area Medica, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy
Email: piaggesi@immr.med.unipi.it
Address: Sezione Dipartimentale Piede Diabetico, Azienda Opspedaliero-Universitaria Pisana, Via Paradisa 2, 56124 Pisa, Italy
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Inclusion criteria were confirmed diabetes, sensory neuropathy tested by a quantitativesomatosensory threshold test using the Semmes-Weinstein 5.07 (10 g) monofilament (on firstand fifth metatarsal heads, medial and lateral midfoot and heel), and a plantar ulcer Grade 1or 2 using the Wagner scale (Wagner 1981). The grade was based on clinical examination andevaluation of a plain radiograph; the location of the ulcer and pre-trial ulcer duration wererecorded.
Excluded criteria: Patients unable to walk indoors, with dementia or life-threatening co-morbidity,ankle/brachial index50.4 and/or osteomyelitis (determined by plain radiograph) wereexcluded.
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Patientrapporteret helbredsrelateret livskvalitet målt med standardiseret spørgeskema, efter endt behandling
Sårheling (total sårlukning (ja/nej)), efter endt behandling
Sårareal, efter endt behandling
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Tryksår, i interventionsperioden
Behandlings adherence/ kompliance, i interventionsperioden, proportion of adherence
Venetrombose, i interventionsperioden
Recidiv af sår, længste follow-up (op til 1 år)
Frafald, alle årsager, efter endt behandling
Sponsorship source: This study was supported by a grant from Convatec Netherlands and the OFOM(Ontwikkelingfonds Orthopedisch Maatschoeisel)
Country: the netherlands
Setting: 43 patients with plantar ulcer Grade 1 or 2 (Wagner scale) wererandomized to one of two off-loading modalities: TCC or CTF.
Authors name: F. B. VAN DE WEG
Institution: Rehabilitation Centre Amsterdam,
Email: f.b.vandeweg@olvg.nl
Address: Ambachtsheerensingel 22, 1393 RE Nigtevecht, The Netherlands
Wrong intervention
Wrong study design
Wrong comparator
Wrong comparator
Wrong study design
Wrong study design
Wrong setting
Wrong study design
Wrong comparator
Wrong intervention
Wrong comparator
Wrong comparator
Wrong study design
Wrong comparator
Wrong study design
Wrong comparator
Wrong comparator
Wrong intervention
Wrong comparator
Wrong intervention
Wrong comparator
Wrong comparator
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "are listed in Table 1. <b>No significant differences were observed in any of the characteristics evaluated, in- cluding age, sex, duration of diabetes, size or location of wounds, or duration of plantar wounds.</b> With the numbers avail- able,"
Quote: "Patients were randomized through a computerized randomization schedule. Randomization was performed after the initial screening."
Quote: "Patients were randomly assigned through a computerized randomization schedule. Randomization was performed after the initial screening,"
Quote: "The randomization required that a patient was assigned to the shoe or cast group by calling the Biometrics Institute, University of Milan, Milan, Italy, where a table of ran- dom numbers was consulted."
Quote: "No noteworthy differences were found between the two groups with respect to clinical characteristics (Table 1). There was no statistical difference in ulcer area at enrollment between the two study groups (431.7 [391.7 mm 2 ] in the shoe group and 587.3 [587.7 mm 2 ] in the cast group, P = 0.415)."
Quote: "No statistical difference was seen between groups in the positioning of the ulcer on the plantar surface of the foot."
Quote: "and bilat- eral plantar ulcers. <b>Clinical characteristics (age, sex, type of diabetes, and duration of diabetes) of both groups were compara- ble. The mean area of the ulcer was 3.4 3.0 cm 2 in group A and 3.9 3.4 cm 2 in group B (NS).</b> No statistical difference was seen"
Quote: "January 2005 and October 2005, <b>60 consecutive dia- betic patients with neuropathic plantar ulcers were seen and randomly assigned to two groups: group</b> A, using an Aircast Pneumatic"
Judgement Comment: Unclear sequence generation
Quote: "The mean age, duration of diabetes, BMI, and glycemic sta- tus of the patients at study entry were statistically insignifi- cant between the 2 groups. The mean surface areas of the plantar ulcers between the groups were also not significant at the baseline (Table 1)."
Quote: "Patients were randomly allocated to 1 of 2 off-loading proce- dures using the randomization table:"
Quote: "Patients were ran- domly assigned to one of the two treat- ment groups by opening randomization codebreak envelopes containing one of the two options. Separate randomization was performed for each center,"
Judgement Comment: Likely random however, unclear how randomisation was performed
Judgement Comment: Unclear randomisation schedule.
Annotation: "The selected patients were randomly allocated into category(...)"
Judgement Comment: A computer-generated list
Quote: "As shown in Table 1, there was no significant difference in distribution of subject characteristics between the two groups (P > .05)."
Quote: "The study was approved by the human studies committee at Washington University School of Medicine, and all patients participating in the study were randomly assigned to either the TCC or TDT group."
Judgement Comment: No information about specific sequence generation. Likely difference in ulcer size.
Quote: "Using a computer generated randomization list, partici- pants were assigned to one of the two off-loading modalities; removable cast walker (RCW, DH Offloading Walker, Ossur, Reykjavik, Iceland) and instant total contact cast (iTCC, the same RCW wrapped with a cohesive bandage, rendering it irremovable; Figure 1)."
Quote: "The patients were then randomized, by means of a remote telephone computer-generated randomization into one of the following 3 groups:"
Quote: "Patients were randomly allocated to one of two off-loading procedures: Total contact cast (TCC) or custom-made temporary footwear (CTF)."
Quote: "An independent person prepared a randomization list in advance with an equal number of treatment assignments (5/5) per block of ten to ensure approximately equal numbers of patients in each treatment group (Pocock 1991)."
Quote: "Differences between both groups were observed with respect to gender and baseline wound surface."
Judgement Comment: OBS: baseline differences
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: No information
Quote: "Randomization was performed after the initial screening, with allocation provided to the treating clinician by a sin- gle study coordinator via telephone."
Judgement Comment: concealed by a phone call of the patients to an office in italy with a random table of numbers for allocation
Judgement Comment: No information
Judgement Comment: No information about allocation concealment.
Quote: "Patients were ran- domly assigned to one of the two treat- ment groups by opening randomization codebreak envelopes containing one of the two options. Separate randomization was performed for each center, and a copy of all randomization envelopes was kept at the statistical department of the Multi- medica center."
Judgement Comment: No information
Judgement Comment: Unclear concealment however, computer generated sequence generation.
Judgement Comment: No information about concealment
Quote: "Sequentially numbered, opaque envelopes that contained the study group assignment were provided to each site. At the time of randomization, an enve- lope was opened by the study coordinator to identify the study group assignment."
Quote: "The patients were then randomized, by means of a remote telephone computer-generated randomization into one of the following 3 groups: group"
Quote: "Allocation was concealed using opaque, sealed envelopes."
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: Not feasible to blind however, no information about blinding of participants.
Judgement Comment: No blinding
Judgement Comment: No information and blinding not feasible.
Judgement Comment: No information about blinding, likely unblinded.
Quote: "Wound care and wound debridement was carried out by a single podiatrist blinded to treatment mode. Tissue"
Judgement Comment: Patients not blinded, participants likely blinded.
Judgement Comment: No blinding.
Judgement Comment: Not feasible to blind participants. No information about blinding of personnel.
Judgement Comment: No information, likely unblinded
Judgement Comment: No information about blinding, likely no blinding (not feasible)
Quote: "predictors to successful wound healing. <b>The person who analyzed the data was blind to the type of intervention.</b> The collected physical activity data"
Judgement Comment: Not feasible to blind patients and investigator not blinded.
Judgement Comment: no blinding
Quote: "All patients attended the out-patient department regularly for device inspection. Wound care and wound debridement was carried out by a podiatrist blinded to treatment mode, and antibiotics dispensed if necessary."
Judgement Comment: Participants not blinded.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: No information however, only objectively measured outcomes of interest.
Judgement Comment: No information about blinding. Outcomes of interest are objectively measured.
Judgement Comment: No information about blinding. Outcomes of interest are objectively measured except patient acceptance.
Judgement Comment: No information about blinding however all outcomes of interest are objectively measured.
Quote: "The area of the wound was then calculated by counting the number of squares in the graph paper and was expressed as cm 2. Photographs were taken of each ulcer."
Judgement Comment: No information about blinding of outcome assessors. Wound size was the only outcome of interest and were objectively measured.
Judgement Comment: No blinding however, only obectively assessed outcomes.
Judgement Comment: No information about blinding of assessors however, only objectively measured outcomes.
Judgement Comment: Blinding not feasible likely influencing self-reported rating of ability to perform daily activites and compliance with device. Other outcomes of interest are "objective"
Judgement Comment: No information about blinding of outcome assessors. However "objectively" measured outcomes.
Quote: "ensure the absence of infection. <b>At each study visit the study coordi- nator took photographs of the wound, which were planimet- rically measured using a 3-D imaging system (Silhouette, ARANZ Systems, Christchurch, New Zealand) and assessed by a clinician unaware of specific study allocation. This pro- vides measures of wound area, length and width. Pre and post treatment photos were taken.</b> Areas of new epithelium or"
Judgement Comment: Only objective outcomes likely blinded..
Quote: "Then the patients were evaluated by an investigator blinded to the offloading device adopted for the patient. A photograph and tracing of the lesion were taken, and the local conditions were assessed in order to check for possible complications or signs of infection."
Quote: "Wound measurement was undertaken by a research assistant blinded for the treatment; patients were instructed not to discuss the treatment with the investigator. The secondary outcome measure was time to wound healing in days.The exact moment of wound closure was identified by a patient’s self-report."
Judgement Comment: Patients not blinded however primarily objective outcomes.
Attrition bias due to amount, nature or handling of incomplete outcome data
Quote: "Of an initial enrollment pool of 75 patients, 12 failed to complete the course of study. Reasons for this included discomfort (four TCC, three RCW), insta- bility (one half-shoe), or failure to return for follow-up appointments and data- collection visits (two TCC, two RCW)."
Judgement Comment: Low attrition rate however, not balanced drop outs (n=6 TCC and 1 from half-show group). Per protocol analysis.
Quote: "Of an initial enrollment pool of 50 patients, 4 failed to complete the course of study. Reasons for this included discomfort/ weight of the device (one RCW, one iTCC) or failure to return for follow-up appoint- ments or data collection visits (two RCW). These patients were considered treatment failures (nonhealers) for the purpose of the intent-to-treat analysis."
Judgement Comment: LIkely no attrition
Quote: "One patient from each group was ex- cluded due to noncompliance."
Judgement Comment: likely no attrition
Quote: "however, 2 patients in the TCC group and 1 patient in the Stabil-D group did not complete the study and were considered dropouts."
Judgement Comment: <10% drop out. Per protocol analysis.
Judgement Comment: 3 vs 0 drop outs from standard dressing and TCC respectively, without reported reasons. Per protocol analysis
Judgement Comment: Patients completing study 78% and 56% in TCC and walker group respectively. Adequate ITT and per protocol analysis. Unbalanced drop outs.
Quote: "Five of 19 (26%) patients in the TDT group showed serious foot infection that required admission to a hospital. Two of these patients required a forefoot am- putation."
Judgement Comment: Likely all 40 patients contributed with outcome data thus no attrition reported.
Judgement Comment: All randomised received group intervention. n= 4 and 2 excluded from analysis in iTCC and RCW respectively. Per protocol analysis.
Quote: "The 65 remaining patients were enrolled and randomized in the 3 groups; 3 patients in group A and 2 in group B did not com- plete the study. Of the patients who interrupted the study, all the patients in group A withdrew consent as did one in group B, whereas the other one was lost to follow-up. All the patients who withdrew consent were treated as per stan- dard of care and all healed within the follow-up period."
Judgement Comment: 3 drop outs from Group A (control) and 0 drop outs from intervention group. Unbalanced drop outs, no information about the three participants.
Quote: "The analysis of effectiveness was done according to the intention-to-treat principle."
Judgement Comment: 2 drop outs from TCC including deviation from intended intervention, however ITT.
Reporting bias due to selective outcome reporting
Judgement Comment: No protocol available. Limited reporting of relevant outcomes.
Judgement Comment: No protocol.
Judgement Comment: No protocol.
Judgement Comment: No protocol available.
Judgement Comment: No protocol available.
Judgement Comment: No protocol.
Judgement Comment: No protocol available. Reporting of critical outcome (amputations and wound healing).
Judgement Comment: No protocol.
Judgement Comment: No protocol.
Judgement Comment: No protocol available.
Judgement Comment: No protocol available. Reporting relevant outcomes of interest.
Judgement Comment: No protocol
Bias due to problems not covered elsewhere in the table
Quote: "This study was funded by the U.S. Department of Veterans Affairs’ Rehabilitation R&D Merit Award Grant A2150RC and the Aircast Research Founda- tion."
Judgement Comment: No description of the roles of the funding parties. Likely limited to funding.
Judgement Comment: No reasons to suspect other sources of bias.
Judgement Comment: No reasons to suspect other sources of bias.
Judgement Comment: No reasons to suspect other sources of bias.
Quote: "The author(s) received no financial support for the research, author- ship, and/or publication of this article."
Quote: "to provide TCCs. Acknowledgments — <b>We acknowledge the contribution of Podartis, Montebelluna, Tre- viso, Italy, manufacturers of the Stabil-D walk- ers used in this study. No other potential conflicts of interest rele- vant to this article were reported.</b> References 1. Boulton AJ. The"
Judgement Comment: No description of Padartis role in the study however, likely limited to funding only.
Judgement Comment: No reasons to suspect other sources of bias.
Judgement Comment: No reasons to suspect other sources of bias.
Quote: "This study was supported by a grant from the Foun- dation for Physical Therapy."
Judgement Comment: no competing interests or other bias' No reasons to suspect other sources of bias.
Quote: "The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The project described was supported in part by a grant from the Qatar National Research Foundation (Award Number NPRP 4-1026-3- 277, http://www.qnrf.org/). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Qatar National Research Foundation. None of the authors employed or contracted by the funder."
Judgement Comment: No reasons to suspect other sources of bias.
Quote: "The author(s) received no financial support for the research, authorship, and/or publication of this article."
Judgement Comment: No reasons to suspect other sources of bias.
Quote: "This study was supported by a grant from Convatec Netherlands and the OFOM (Ontwikkelingfonds Orthopedisch Maatschoeisel). Neither was involved in the handling of data in any way or in the publication of this manuscript."
Judgement Comment: No reasons to suspect other sources of bias.