Removable Walker for Neuropathic Ulcers

Phase 3

Completed

• Conditions: Diabetic Foot
• Interventions: Device: non-removable fiberglass; Device: Stabil-D®

• Registration Number: NCT01005264
• Lead Sponsor: IRCCS Multimedica

Brief Summary

1. 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

2. 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

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).

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-10
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-29
• Last Update Submitted: 2009-10-29
• Study First Posted: 2009-10-30
• Last Update Posted: 2009-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-removable fiberglass	non-removable fiberglass	Softcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus
Stabil-D®	Stabil-D®	Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole

Primary Outcome Measures

Name	Time	Method
Decrease in ulcer size	at 90th day

Secondary Outcome Measures

Name	Time	Method
Complete healing rate at the end of the study	at 90th day

Trial Locations

Locations (1)

Diabetic Foot Center - IRCCS Multimedica; 🇮🇹 Sesto San Giovanni, Milan, Italy