Clinical trial NCT01005264: Removable Walker for Neuropathic Ulcers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Foot
Keywords: diabetic foot
neuropathic plantar ulcer
ulcer healing
non-removable total contact cast
removable cast walker
Lead sponsor: IRCCS Multimedica
Sponsor class: OTHER
First posted: 2009-10-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Decrease in ulcer size
timeFrame: at 90th day
Secondary outcomes:
measure: Complete healing rate at the end of the study
timeFrame: at 90th day
Other outcomes:
Locations:
city: Sesto San Giovanni
country: Italy
facility: Diabetic Foot Center - IRCCS Multimedica
state: Milan
Study officials:
affiliation: Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy
name: Ezio Faglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 plantar ulcers: a randomized prospective trial. Diabetes Care. 2007 Oct;30(10):2577-8. doi: 10.2337/dc07-0990. Epub 2007 Jun 11. No abstract available.
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 traditional fiberglass cast. Diabetes Care. 2007 Mar;30(3):586-90. doi: 10.2337/dc06-1750.
citation: 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 randomized study. Diabetes Care. 2000 Dec;23(12):1746-51. doi: 10.2337/diacare.23.12.1746.
citation: Faglia E, Caravaggi C, Clerici G, Sganzaroli A, Curci V, Vailati W, Simonetti D, Sommalvico F. Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. Diabetes Care. 2010 Jul;33(7):1419-23. doi: 10.2337/dc09-1708. Epub 2010 Mar 31.