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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Withdrawn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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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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