[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: diabetic patients with plantar forefoot ulceration
Excluded criteria: no exclusion criteria
Intervention Characteristics
Intervention
Kontrol
Recidiv af sår, længste follow-up (op til 1 år)
Sårheling, længste follow-up (op til 1 år)
Bivirkninger (DVT, lungeemboli, komplikationer i relation til operationssår), længste follow-up (op til 1 år)
Transfersår, Længste follow-up (op til 1 år)
Sponsorship source: no funding
Country: egypt
Setting: Twenty nine diabetic patients with plantar forefoot ulceration were randomized into two groups: TCC og ATL at a university hospital
Authors name: abdel mohsen allam
Institution: The Department of General Surgery, Plastic & Reconstructive Surgery Unit, Tanta University.
Email: no email
Address: The Department of General Surgery, Plastic & Reconstructive Surgery Unit, Tanta University. El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Patients were considered for inclusion in the study if they had ahistory of diabetes mellitus, loss of protective sensation (unableto sense the 5.07 Semmes-Weinstein monofilament on at leastone location on the plantar aspect of the foot), limitation of an-kle dorsiflexion to ≤5°, a palpable ankle pulse, and a recurrentor nonhealing ulcer on the forefoot (Grade II according to theWa g n e r s c a l e21). A limitation of 5° of ankle dorsiflexion waschosen because most authors believe that ≥10° is required fornormal walking ability22. A recurrent or nonhealing ulcer wasdefined as two or more occurrences of a plantar ulcer or the fail-ure of a plantar ulcer to heal with conservative treatment (i.e.,dressing changes and footwear modifications).
Excluded criteria: Patients were excluded from the study if they had a neurologi-cal problem complicating the rehabilitation, had a history ofCharcot fractures of the hindfoot, were unable to tolerate theanesthesia required for Achilles tendon lengthening, or if itwas thought that they would not benefit from an Achilles ten-don lengthening (i.e., they were not able to walk). We did notexclude individuals with a Charcot deformity of the midfootor forefoot or a partial foot amputation if they met the aboveinclusion criteria.
Intervention Characteristics
Intervention 1
Kontrol 1
Helbredsrelateret livskvalitet, længste follow-up (op til 1 år)
Selvrapporteret funktion, efter endt behandling
Sponsorship source: funding from the National Center for Medical Rehabilitation Research and the National Institutes of Health RO1 HD 36802.
Country: USA
Setting: Sixty-four subjects were randomized into two treatment groups, immobilization in a total-contact cast alone orcombined with percutaneous Achilles tendon lengthening, with measurements made before and after treatment, at theseven-month follow-up examination, and at the final follow-up evaluation (a mean [and standard deviation] of 2.1 ± 0.7years after initial healing).
Authors name: Michael J Mueller
Institution: Washington University School of Medicine, St. Louis, Missouri
Email: muellermi@msnotes.wustl.edu
Address: Program in Physical Therapy, Box 8502, 4444 Forest Park Boulevard, St. Louis, MO 63018.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Inclu-sion criteria were a diagnosis of diabetes,inability to sense a 5.07 (10-g) SemmesWeinstein monofilament on at least onelocation on the plantar surface of the foot(indicating loss of protective sensation), arecurrent (i.e., two or more episodes)Wagner grade II ulcer (3) on the plantarforefoot or toes, and5°of passive dor-siflexion range of motion at the talocruraljoint as measured using a goniometerwith the knee extended.
Excluded criteria: Patients were ex-cluded from participation in the study ifthey were nonambulatory, had a historyof rear foot Charcot fractures, had im-paired circulation indicated by an ankle-arm index0.45, or reported a history ofsignificant health problems that renderedthem medically unfit for surgery or post-surgical rehabilitation
Intervention Characteristics
Intervention 1
Kontrol 1
Underekstremitets amputationer, længste follow-up (op til 1 år)
Recidiv af sår, længste follow-up (op til 1 år)
Mobiliseringsgrad, efter endt behandling
Sårheling (total sårlukning), længste follow-up (op til 1 år)
Sårareal, længste follow-up (op til 1 år)
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Bivirkninger (DVT, lungeemboli, komplikationer i relation til operationssår), længste follow-up (op til 1 år)
Transfersår, længste follow-up (op til 1 år)
Sponsorship source: Funding was provided by the National Center for Medical Rehabilitation Research, the National Institutes of Health Grant RO1-HD-36802.
Country: USA
Setting: Prevention and Control Research Core of the Washington University Diabetes Research Training Center,
Authors name: Michael J Mueller
Institution: Applied Biomechanics Laboratory, Program in Physical Therapy, Washington University Schoolof Medicine, St. Louis, Missouri
Email: muellerm@wustl.edu
Address: P.O. Box 8502, 4444 ForestPark Blvd., St. Louis, MO 63108
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Inclusion criteria were: diabetes mellitus (DM), eitherType 1 or Type 2, of at least 5 years’ duration; presenceof one or more painless foot ulcers with clinicalcharacteristics of neuropathy (symptomatic peripheralneuropathy assessed with the Michigan NeuropathyScreening Instrument (MNSI), absence of ankle reflexes,and abnormal vibration perception threshold(VPT.25 V) at malleolus and first toe, according to themethodology described by Younget al.8,9)
Excluded criteria: Exclusion criteria were: presence of symptomaticclaudication or absence of foot pulses, recent keto-acidosis, renal failure as suggested by creatinine higherthan 177mmol l−1, presence of infection as indicated byperilesional oedema and erythema, or presence of pus,systemic symptoms like fever or leukocytosis. In casesof doubt, a wound swab was sent for bacteriologicalassessment and no suspicious case was enrolled. Patientswith congenital foot deformities or diabetic neuroarthro-pathy, body mass index (BMI).30 kg m−2, clinicalhistory of stroke, cardiac failure, cancer, HIV positivityor history of mental illness were also excluded.To exclude the possibility of subclinical macroangio-pathy, a Doppler study was performed in any case ofreduced peripheral pulses. An ankle-brachial pressureindex (ABPI) less than 0.9 excluded patients from thestudy. Osteomyelitis was suspected in any case in whichthe bone or the joint could be probed through the ulcer.In such cases an X-ray of the foot was examined forsigns of osteomyelitis; doubtful cases were excluded
Intervention Characteristics
Intervention 1
Kontrol 1
Helbredsrelateret livskvalitet, længste follow-up (op til 1 år)
Underekstremitets amputationer, længste follow-up (op til 1 år)
Recidiv af sår, længste follow-up (op til 1 år)
Mobiliseringsgrad, efter endt behandling
Sårheling (total sårlukning), længste follow-up (op til 1 år)
Sårareal, længste follow-up (op til 1 år)
Infektion (positiv dyrkning, eller klinisk (rødme, pus, lugt, hævelse, smerte)), i interventionsperioden
Bivirkninger (DVT, lungeemboli, komplikationer i relation til operationssår), længste follow-up (op til 1 år)
Transfersår, længste follow-up (op til 1 år)
Sponsorship source: no sponsors
Country: italy
Setting: To test the efficacy of surgical treatment of non-infected neuropathic foot ulcers comparedto conventional non-surgical management, a group of diabetic outpatients attending ourdiabetic foot clinic were studied. Group A received conservative treatment, consisting of reliefof weight-bearing, regular dressings; group B underwent surgical excision, eventualdebridement or removal of bone segments underlying the lesion and surgical closure
Authors name: Alberto Piaggesi
Institution: Cattedra di Malattie del Metabolismo, Istituto di Clinica Medica II,Universita`di Pisa, Pisa, Italy
Email: no email
Address: Unita`Operativa Malattiedel Ricambio, Azienda Ospedaliera Pisana, Via Paradisa 2, 56100Pisa, Italy
Wrong study design
Wrong intervention
Surgical offloading procedures for diabetic foot ulcers compared to best non-surgical treatment: a study protocol for a randomized controlled trial
RCT
Diabetic foot ulcers
Surgical offloading procedures vs best non-surgical treatment
Outcome criteria will be time to healing of the primary ulcer (complete epithelization), time to healing of surgical wound, recurrence of ulcer, time to
recurrence and complications
2018
asff@inter.net.il
Protocol registration: https://my.health.gov.il/CliniTrials/Pages/MOH_2017-08-10_000719.aspx
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "forefoot ulceration. MATERIAL AND METHODS <b>Twenty nine diabetic patients with plantar forefoot ulceration were randomized into two groups: • Group I (GI): 14 patients were managed by local wound care and total contact cast alone (TCC). • Group II (GII): 15 patients were treated by local ulcer care and Achilles tendon lengthening (ATL).</b> Postoperatively, the patients were followed"
Quote: "There were no significant differences in age, sex, or the duration of the plantar forefoot ulcerations between the studied groups."
Judgement Comment: No information about randomisation method.
Quote: "were randomized into the Achilles tendon lengthen- ing group or the total-contact cast group with use of a prear- ranged schedule generated by a computer program."Quote: "Randomization methods were successful as there were no differences between the groups with respect to any subject characteristic (p > 0.05)."Quote: "There were no differences between groups (p > 0.05) for any of these characteristics."Judgement Comment: No baseline differences
Quote: "The groups were not signifi- cantly different with regard to age, eth- nicity, BMI, duration of diabetes, HbA 1c, sex composition, or the proportion of subjects with type 1 and type 2 diabetes (Table 1)."Quote: "Subjects were randomly assigned to treatment with an ATL procedure fol- lowed by TCC (ATL group; n 31) or treatment with TCC alone (TCC group; n 33)."Judgement Comment: From other publication: "Subjects were randomized into the Achilles tendon lengthen- ing group or the total-contact cast group with use of a prear- ranged schedule generated by a computer program." No baseline differences
Quote: "After having obtained their informed consent, patients were randomized into two groups according to a table of randomization:"Judgement Comment: Unclear how a RANDOM randomization was performed however, no apparent baseline differences between groups (ANOVA analysis not shown)
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: Not described. Likely no efforts made to conceal allocation.
Quote: "were un- likely to meet. <b>The orthopaedic surgeon (J.E.J.), who screened all patients for eligibility into the study, was blind to the prear- ranged schedule. Once the subject agreed to participate, he or she was referred to the patient coordinator for the study who assigned the subject to a treatment group according to the prearranged schedule and arranged all testing sessions.</b> Subject Characteristics Sixty-four subjects met"Judgement Comment: Unclear how the patient coordinator concealed the allocation for patients and personnel until after testing sessions.
Judgement Comment: No information about allocation concealment
Judgement Comment: Ni information about who performed the sequence generation and if the allocation was concealed.
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: No blinding of participants. No information about blinding of the personnel.
Quote: "Because we anticipated a much higher rate of reulceration in the total- contact cast group compared with that in the Achilles tendon lengthening group 6, and we wanted subjects to have the op- portunity to cross over to the Achilles tendon lengthening group if treatment with a total-contact cast alone was not suc- cessful, the prearranged schedule was planned to enroll two times as many subjects in the total-contact cast group as in the Achilles tendon lengthening group. Subjects who had a reul- ceration after treatment with a total-contact cast were then al- lowed to enter the Achilles tendon lengthening group."Judgement Comment: Personnel not blinded. No sham surgery
Judgement Comment: No information about blinding, likely particpants and personnel are unblinded
Judgement Comment: Efforts made to blind personnel. No efforts to blind described participants, No sham surgery.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: No description of blinding of outcome assessors. Likely no efforts made to blind.
Judgement Comment: Not blinded outcome assessors however, only objectively assessed outcomes.
Judgement Comment: No blinded of participants, self-reported outcomes.
Judgement Comment: No information about blinding however, primarily objectively assessed outcomes
Attrition bias due to amount, nature or handling of incomplete outcome data
Quote: "29 diabetic patients with plantar forefoot ulceration were allocated in two groups"
Judgement Comment: No information about drop outs. Alle participants informed outcomes of interest for all time points.
Judgement Comment: Low attrition however, per protocol analysis (No ITT or description of drop outs)
Quote: "n 14; TCC, n 14). <b>The number of subjects reported in the analyses varies (see Tables 2 and 3) because not all data were available on all 28 subjects.</b> The groups were not signifi-"Quote: "A smaller subset of subjects agreed to additional testing as described in this study. Therefore, the analyses de- scribed in this study include only those subjects who completed testing on all three test occasions (ATL, n 14; TCC, n 14)."Judgement Comment: of 64 participants, only 28 completed SR measures (all time points) unclear attrition. PP analysis.
Judgement Comment: 20/21 randomised. NI about drop outs or missing data.
Reporting bias due to selective outcome reporting
Judgement Comment: Only early complications reported for ATL group. No protocol
Judgement Comment: No protocol available. Only reporting self-reported data from participants with follow-up data from all time points in seperate publication. Thorough reporting of relevant outcomes.
Judgement Comment: No protocol available. Only reporting data from participants with follow-up data from all time points.
Judgement Comment: No protocol registered however, anticipated outcomes thoroughly reported
Bias due to problems not covered elsewhere in the table
Judgement Comment: Only one author. No information about funding etc...
Quote: "8233, St. Louis, MO 63110 <b>In support of their research or preparation of this manuscript, one or more of the authors received grants or outside funding from the National Center for Medical Rehabilitation Research and the National Institutes of Health RO1 HD 36802. None of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.</b> "Judgement Comment: No reason 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