Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT00330265. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus. This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study. Participation in the study is for 24 weeks.
Study identification
- NCT ID
- NCT00330265
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2005
- Primary completion
- Feb 28, 2009
- Completion
- Aug 31, 2009
- Last update posted
- Aug 25, 2008
2006 – 2009
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Institute for Advanced Wound Care at Baptist Medical Center South | Montgomery | Alabama | 36111 | Recruiting |
| HOPE Research Institute | Phoenix | Arizona | 85050 | Recruiting |
| Southern Arizona VA Health Care System | Tucson | Arizona | 85723 | Recruiting |
| Roy Kroeker, DPM | Fresno | California | 93710 | Recruiting |
| Felix Sigal, DPM | Los Angeles | California | 90010 | Recruiting |
| Bay Area Foot Care | San Francisco | California | 94115 | Recruiting |
| North American Center for Limb Preservation | New Haven | Connecticut | 06515 | Recruiting |
| Georgetown University / Wound Healing Center | Washington D.C. | District of Columbia | 20007 | Recruiting |
| Doctor's Research Network | South Miami | Florida | 33143 | Recruiting |
| Medical Associates | Clinton | Iowa | 52732 | Recruiting |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | Recruiting |
| Preston Family Building | Boston | Massachusetts | 02118 | Recruiting |
| Foot Healthcare Associates, PC | Livonia | Michigan | 48152 | Recruiting |
| St. Vincent Health Center Wound Clinic | Erie | Pennsylvania | 16444 | Recruiting |
| Pivotal Clinical Research | Souderton | Pennsylvania | 18964 | Recruiting |
| Warren General Hospital Wound Clinic | Warren | Pennsylvania | 16365 | Recruiting |
| Martin Foot and Ankle | York | Pennsylvania | 17403 | Recruiting |
| San Antonio Podiatry Associates, PC | San Antonio | Texas | 78229 | Recruiting |
| Pharmaceutical Research Organization | Bountiful | Utah | 84010 | Recruiting |
| Dixie Regional Medical Center's Wound Clinic | St. George | Utah | 84770 | Recruiting |
| Central Washington Podiatry Service | Yakima | Washington | 98902 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00330265, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2008 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00330265 live on ClinicalTrials.gov.