Removable Walker for Neuropathic Ulcers

Sponsor

IRCCS Multimedica (Other)

Overall Status

Completed

CT.gov ID

NCT01005264

Collaborator

(none)

Enrollment

Location

Arms

12.9

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot	Device: non-removable fiberglass Device: Stabil-D®	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: non-removable fiberglass

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

Device: non-removable fiberglass

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

Other Names:

Softcast3M®, 3M Health Care, St. Paul, MN (USA)

Active Comparator: Stabil-D®

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

Device: Stabil-D®

Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole

Other Names:

Podartis srl, Montebelluna, Treviso, Italy

Outcome Measures

Primary Outcome Measures

Decrease in ulcer size [at 90th day]

Secondary Outcome Measures

Complete healing rate at the end of the study [at 90th day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.