Removable Walker for Neuropathic Ulcers

Diabetic Foot Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005264
• Other study ID #: 05/2007cardiovascolare
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2009
• Last updated: October 29, 2009
• Start date: February 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2009
• Source: IRCCS Multimedica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

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

Locations

Country	Name	City	State
Italy	Diabetic Foot Center - IRCCS Multimedica	Sesto San Giovanni	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Multimedica

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Caravaggi C, Faglia E, De Giglio R, Mantero M, Quarantiello A, Sommariva E, Gino M, Pritelli C, Morabito A. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a ran — View Citation

Caravaggi C, Sganzaroli A, Fabbi M, Cavaiani P, Pogliaghi I, Ferraresi R, Capello F, Morabito A. Nonwindowed nonremovable fiberglass off-loading cast versus removable pneumatic cast (AircastXP Diabetic Walker) in the treatment of neuropathic noninfected p — View Citation

Piaggesi A, Macchiarini S, Rizzo L, Palumbo F, Tedeschi A, Nobili LA, Leporati E, Scire V, Teobaldi I, Del Prato S. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus tradition — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in ulcer size		at 90th day	Yes
Secondary	Complete healing rate at the end of the study		at 90th day	Yes