Removable Walker for Neuropathic Ulcers

NCT01005264 | Completed Phase 3

• 1 other identifier: 05/2007cardiovascolare
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Diabetic Foot

Keywords

diabetic foot; neuropathic plantar ulcer; ulcer healing; non-removable total contact cast; removable cast walker

Outcome Measures

Primary Outcomes (1)

• Decrease in ulcer size

  at 90th day

Secondary Outcomes (1)

• Complete healing rate at the end of the study

  at 90th day

Study Arms (2)

non-removable fiberglass

ACTIVE COMPARATOR

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

Device: non-removable fiberglass

Stabil-D®

ACTIVE COMPARATOR

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

Device: Stabil-D®

Interventions

non-removable fiberglass DEVICE

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

Also known as: Softcast3M®, 3M Health Care, St. Paul, MN (USA)

non-removable fiberglass

Stabil-D® DEVICE

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

Also known as: Podartis srl, Montebelluna, Treviso, Italy

Stabil-D®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Multimedica: lead

Study Sites (1)

Diabetic Foot Center - IRCCS Multimedica

Sesto San Giovanni, Milan, 20099, Italy

Location

Related Publications (4)

• 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.

  PMID: 17563333 RESULT

• 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.

  PMID: 17327325 RESULT

• 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.

  PMID: 11128345 RESULT

• 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.

  PMID: 20357377 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Ezio Faglia, MD

  Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 30, 2009
• Study Start: February 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 30, 2009

Record last verified: 2009-10

Locations

IT (1)