Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds
Primary Purpose
Wounds
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
debridement
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring sharp debridment, patients with full thickness wounds of greater than 30 days duration
Eligibility Criteria
Inclusion Criteria:
- Subject must have evidence of a full-thickness cutaneous wound of at least 30 days duration.
- Subject must be at least 18 years of age.
- Subject must have a minimum life expectancy of at least 1 year to be determined by the Investigator.
- The study ulcer must be from 1 cm2 to 20 cm2 in size.
- The study ulcer must have been present for at least 30 days at study Day -7.
- The subject's Glycosylated hemoglobin (HbA1C) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study Day 0.
- The subject, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form.
- 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.
- 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:
- 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
- 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.
- Participation in clinical trials evaluating investigational pharmaceuticals, biologics or devices within 30 days of admission to the study.
- 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.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
debridement
Arm Description
monthly vs weekly debridement
Outcomes
Primary Outcome Measures
The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group.
Secondary Outcome Measures
The major secondary objectives are incidence of complete wound closure at Week 12, rate of healing, ulcer recurrence, wound characteristics, and microbiologic information.
Full Information
NCT ID
NCT00990522
First Posted
October 6, 2009
Last Updated
December 10, 2015
Sponsor
Southwest Regional Wound Care Center
1. Study Identification
Unique Protocol Identification Number
NCT00990522
Brief Title
Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds
Official Title
A Prospective, Randomized, Controlled Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled, per PI discretion
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Regional Wound Care Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
sharp debridment, patients with full thickness wounds of greater than 30 days duration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
debridement
Arm Type
Experimental
Arm Description
monthly vs weekly debridement
Intervention Type
Procedure
Intervention Name(s)
debridement
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must have evidence of a full-thickness cutaneous wound of at least 30 days duration.
Subject must be at least 18 years of age.
Subject must have a minimum life expectancy of at least 1 year to be determined by the Investigator.
The study ulcer must be from 1 cm2 to 20 cm2 in size.
The study ulcer must have been present for at least 30 days at study Day -7.
The subject's Glycosylated hemoglobin (HbA1C) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study Day 0.
The subject, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form.
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.
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:
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
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.
Participation in clinical trials evaluating investigational pharmaceuticals, biologics or devices within 30 days of admission to the study.
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Wolcott, M.D.
Organizational Affiliation
Southwest Regional Wound Care Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds
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