Removable Walker for Neuropathic Ulcers

This study has been completed.
Sponsor:
Information provided by:
IRCCS Multimedica
ClinicalTrials.gov Identifier:
NCT01005264
First received: October 19, 2009
Last updated: October 29, 2009
Last verified: October 2009
  Purpose
  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.

Condition Intervention Phase
Diabetic Foot
Device: non-removable fiberglass
Device: Stabil-D®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by IRCCS Multimedica:

Primary Outcome Measures:
  • Decrease in ulcer size [ Time Frame: at 90th day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete healing rate at the end of the study [ Time Frame: at 90th day ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Podartis srl, Montebelluna, Treviso, Italy

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005264

Locations
Italy
Diabetic Foot Center - IRCCS Multimedica
Sesto San Giovanni, Milan, Italy, 20099
Sponsors and Collaborators
IRCCS Multimedica
Investigators
Principal Investigator: Ezio Faglia, MD Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ezio Faglia MD, Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy
ClinicalTrials.gov Identifier: NCT01005264     History of Changes
Other Study ID Numbers: 05/2007cardiovascolare
Study First Received: October 19, 2009
Last Updated: October 29, 2009
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by IRCCS Multimedica:
diabetic foot
neuropathic plantar ulcer
ulcer healing
non-removable total contact cast
removable cast walker

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on September 18, 2014