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

Wounds Clinical Trial

Official title:

A Prospective, Randomized, Controlled Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00990522
• Other study ID #: 56-RW-014
• Status: Withdrawn
• Phase: N/A
• First received: October 6, 2009
• Last updated: December 10, 2015
• Start date: May 2009
• Est. completion date: February 2011

Study information

• Verified date: December 2015
• Source: Southwest Regional Wound Care Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Regional Wound Care Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group.		12 weeks	No
Secondary	The major secondary objectives are incidence of complete wound closure at Week 12, rate of healing, ulcer recurrence, wound characteristics, and microbiologic information.		12 weeks	No

External Links

•   Southwest Regional Wound Care Center