Removable Walker for Neuropathic Ulcers

IRCCS Multimedica

Status and phase: Completed; Phase 3

Conditions: Diabetic Foot

Treatments: Device: Stabil-D®; Device: non-removable fiberglass

Study type: Interventional

Funder types: Other

Identifiers

NCT01005264

05/2007cardiovascolare

Details and patient eligibility

About

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.

Full 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).

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

non-removable fiberglass

Active Comparator group

Description:

Softcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus

Treatment:

Device: non-removable fiberglass

Stabil-D®

Active Comparator group

Description:

Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole

Treatment:

Device: Stabil-D®