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| Sponsored by: |
KCI USA, Inc. |
|---|---|
| Information provided by: | KCI USA, Inc. |
| ClinicalTrials.gov Identifier: | NCT00605189 |
Purpose
A randomized, controlled pilot study examining how cellular energetics and oxygenation levels are related to various wound treatment therapies in patients with diabetic foot ulcers.
| Condition | Intervention |
|---|---|
|
Diabetic Foot Ulcers |
Device: Powered Suction Pump (VAC Freedom) Device: Powered Suction Pump Other: Moist Wound Therapy (Allevyn, Tielle, SoloSite, Curagel) |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Open Label, Parallel Assignment |
| Official Title: | A Randomized, Controlled Trial Examining Cellular Energetics and Oxygenation Levels Related To Various Wound Treatment Therapies |
| Estimated Enrollment: | 39 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | August 2008 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| I: Active Comparator |
Device: Powered Suction Pump (VAC Freedom)
continuous suction
|
| II: Active Comparator |
Device: Powered Suction Pump
continuous suction
|
| III: Placebo Comparator |
Other: Moist Wound Therapy (Allevyn, Tielle, SoloSite, Curagel)
Foam Dressings, Hydrogel Impregnated Gauze, Hydrogel Sheet Dressings
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| North American Center of Limb Preservation | Recruiting |
| New Haven, Connecticut, United States, 06515 | |
| Contact: Michael Palladino, DPM 203-397-0624 mpads@aol.com | |
| Contact: Sejal Patel 203-397-0624 | |
| Principal Investigator: Peter Blume, DPM | |
| United States, North Carolina | |
| Moore Foot and Ankle Specialists, PA | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: LeeAnn Van Eyk 828-350-1880 mfas828@aol.com | |
| Principal Investigator: J. Christopher Moore, DPM | |
| Sub-Investigator: Lily L Moore, DPM | |
| Coastal Surgical Specialists, PA | Recruiting |
| New Bern, North Carolina, United States, 28560 | |
| Contact: Virginia Wetherington 252-902-6384 | |
| Principal Investigator: William H Bell, MD | |
| United States, Ohio | |
| The Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Lee Underman 614-293-0390 | |
| Principal Investigator: Gayle M Gordillo, MD | |
| Sub-Investigator: Chandan K Sen, PhD | |
| United States, Texas | |
| University of Texas Health Science Center San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Krista Kilpadi, PhD 210-567-6292 | |
| Contact: Victor Sylvia, PhD 210-567-6328 | |
| Principal Investigator: Thomas Zgonis, DPM | |
| Study Director: | Kris Kieswetter, PhD | KCI USA, Inc. |
More Information
| Responsible Party: | KCI ( Director Clinical Reserach ) |
| Study ID Numbers: | VACP2005-009 |
| Study First Received: | December 20, 2007 |
| Last Updated: | April 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00605189 |
| Health Authority: | United States: Institutional Review Board |
|
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Foot Diseases Diabetic Angiopathies Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
|
Cardiovascular Diseases |
