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Trial record 1 of 2 for:    stabil-d
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Removable Walker for Neuropathic Ulcers

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ClinicalTrials.gov Identifier: NCT01005264
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : October 30, 2009
Sponsor:
Information provided by:
IRCCS Multimedica

Tracking Information
First Submitted Date  ICMJE October 19, 2009
First Posted Date  ICMJE October 30, 2009
Last Update Posted Date October 30, 2009
Study Start Date  ICMJE February 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Decrease in ulcer size [ Time Frame: at 90th day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Complete healing rate at the end of the study [ Time Frame: at 90th day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Removable Walker for Neuropathic Ulcers
Official Title  ICMJE Effectiveness of Removable Walker Cast Versus Non-removable Fiberglass Off-bearing Cast in the Healing of Diabetic Plantar Foot Ulcer- a Randomized Controlled Trial
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • Active Comparator: non-removable fiberglass
    Softcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus
    Intervention: Device: non-removable fiberglass
  • Active Comparator: Stabil-D®
    Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole
    Intervention: Device: Stabil-D®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2009)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01005264
Other Study ID Numbers  ICMJE 05/2007cardiovascolare
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ezio Faglia MD, Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy
Study Sponsor  ICMJE IRCCS Multimedica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ezio Faglia, MD Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy
PRS Account IRCCS Multimedica
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP