Removable Walker for Neuropathic Ulcers

Study Overview
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Brief Summary
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Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.

Detailed Description
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Study design: Two centers specializing in diabetic foot management (located in Sesto S. Giovanni and Milan, Italy) participated to this open, randomized clinical trial. The ethics-committee approved the study on January 10th, 2008. Enrollment of consecutive patients began February 2008 and ended March 2009. Eligible patients were fully informed of the study aim and procedures and written consent was obtained prior to study participation. Patients were then randomly assigned to one of the two treatment 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 Multimedica center. The two arms were composed of patients managed with non-removable fiberglass off-bearing cast (TCC group) and patients offloaded with the Stabil-D® (Podartis srl, Montebelluna, Treviso, Italy) walker cast (Stabil-D group).

Official Title
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Effectiveness of Removable Walker Cast Versus Non-removable Fiberglass Off-bearing Cast in the Healing of Diabetic Plantar Foot Ulcer- a Randomized Controlled Trial

Conditions
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Diabetic Foot

Intervention / Treatment
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* Device: non-removable fiberglass
* Device: Stabil-D®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts. Exclusion Criteria: Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot, Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage, The probe-to-bone maneuver was required to be negative, Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis, Use of steroids or cytostatic drugs, Presence of sensory, motor, or visual problems that could impair functional autonomy, Active ulcer on the contralateral foot, Previous major amputation of the contralateral limb, Previous or current deep venous leg thrombosis, OR Mental disorders interfering with patient compliance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-removable fiberglass<br>Softcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus | Device: non-removable fiberglass<br>* Two types of fiberglass bandages (Softcast3M®, 3M Health Care, St. Paul, MN (USA)) were used for construction of the pressure-relief apparatus<br>* Other names: Softcast3M®, 3M Health Care, St. Paul, MN (USA);|
| Active Comparator: Stabil-D®<br>Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole | Device: Stabil-D®<br>* Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole<br>* Other names: Podartis srl, Montebelluna, Treviso, Italy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in ulcer size |  | at 90th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete healing rate at the end of the study |  | at 90th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot, neuropathic plantar ulcer, ulcer healing, non-removable total contact cast, removable cast walker