Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT00990522
First received: October 6, 2009
Last updated: September 6, 2011
Last verified: September 2011

October 6, 2009
September 6, 2011
May 2009
February 2011   (final data collection date for primary outcome measure)
The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00990522 on ClinicalTrials.gov Archive Site
The major secondary objectives are incidence of complete wound closure at Week 12, rate of healing, ulcer recurrence, wound characteristics, and microbiologic information. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds
A Prospective, Randomized, Controlled Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds

Standard care of care and up to twelve (12) weekly debridements. Subjects randomized into the weekly debridement group will receive up to twelve (12) debridement during the twelve (12) weeks of the study. There will be two (2) subject groups in the study. Subjects will be randomized into either the monthly debridement group or the weekly debridement group.

The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group.

The major secondary objectives are incidence of complete wound closure at Week 12, rate of healing, ulcer recurrence, wound characteristics, and microbiologic information.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Wounds
Procedure: debridement
There will be two (2) subject groups in the study. Subjects will be randomized into either the monthly debridement group or the weekly debridement group.
Experimental: debridement
monthly vs weekly debridement
Intervention: Procedure: debridement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
0
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject must have evidence of a full-thickness cutaneous wound of at least 30 days duration.
  2. Subject must be at least 18 years of age.
  3. Subject must have a minimum life expectancy of at least 1 year to be determined by the Investigator.
  4. The study ulcer must be from 1 cm2 to 20 cm2 in size.
  5. The study ulcer must have been present for at least 30 days at study Day -7.
  6. The subject's Glycosylated hemoglobin (HbA1C) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study Day 0.
  7. The subject, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form.
  8. The subject must be available for evaluation on a weekly basis for the twelve (12) weeks of the study. Visits at Week 13 and Week 14 are required for initial wound healing, which is achieved in study Week 11 or 12. The Investigator will evaluate both groups at Week 16. Subjects must be available for evaluation at Week 16.
  9. The subject's TCpO2 must be equal to or greater than 25 mm of mercury in the periwound area and ABI greater than 0.7.

Exclusion Criteria:

  1. Subject whose ulcer has healed 30% or greater from the evaluation Study day -7 to the post-debridement Study Day 0 as determined by wound measurements using ARANZ Silhouette
  2. A history of alcohol or substance abuse, within the previous year, which could, or in the judgment of the Investigator, would interfere with study compliance or protocol requirements.
  3. Participation in clinical trials evaluating investigational pharmaceuticals, biologics or devices within 30 days of admission to the study.
  4. Subject with a history of receiving any of the following within the last 30 days: systemic corticosteroids exceeding a total daily dose of 20mg, immunosuppressive agents, radiation therapy or chemotherapy. Anticipated use of the above during the study period will also exclude a subject from entry into the study. Topical and inhaled corticosteroids are not prohibited.
  5. Subjects with medical comorbidities known to affect wound healing such as end stage renal disease, severe hepatic insufficiency, vasculitis, and HIV will be excluded from this study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00990522
56-RW-014
No
Randall Wolcott, Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
Not Provided
Principal Investigator: Randall Wolcott, M.D. Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
September 2011

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