Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers (KC-002PT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by KeraCure.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
KeraCure
Information provided by:
KeraCure
ClinicalTrials.gov Identifier:
NCT00330265
First received: May 24, 2006
Last updated: August 25, 2008
Last verified: August 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Foot Ulcer Diabetes |
Device: KC-002 Other: Conventional Wound Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by KeraCure:
Primary Outcome Measures:
- Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
KC-002
|
Device: KC-002
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.
|
|
2
Conventional Wound Therapy
|
Other: Conventional Wound Therapy
Normal Saline Dressings
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Participants included in the study must:
- Have Type 1 or Type 2 diabetes mellitus
- Have a diabetic foot ulcer on the bottom of the foot or heal which has been present for three (3) weeks but less than two (2) years and is sufficient size to qualify for the study
- Be able to visit the study doctor regularly for 24 weeks
Exclusion Criteria:
Participants may not be included if:
- The diabetic foot ulcer is infected
- They have poor circulation in their study foot
- Cannot or will not wear a special boot to take pressure off the study ulcer
- They have certain other diseases or laboratory values which are not within a specified range
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330265
Contacts
| Contact: M Meek | 866-537-2287 | clinicaltrial@keracure.com |
Locations
| United States, Alabama | |
| Institute for Advanced Wound Care at Baptist Medical Center South | Recruiting |
| Montgomery, Alabama, United States, 36111 | |
| Contact 334-286-3444 | |
| United States, Arizona | |
| HOPE Research Institute | Recruiting |
| Phoenix, Arizona, United States, 85050 | |
| Contact 602-274-4100 | |
| Southern Arizona VA Health Care System | Recruiting |
| Tucson, Arizona, United States, 85723 | |
| Contact 520-792-1450 | |
| United States, California | |
| Roy Kroeker, DPM | Recruiting |
| Fresno, California, United States, 93710 | |
| Contact 559-436-8162 | |
| Felix Sigal, DPM | Recruiting |
| Los Angeles, California, United States, 90010 | |
| Contact 888-860-4325 | |
| Bay Area Foot Care | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact 415-292-0638 | |
| United States, Connecticut | |
| North American Center for Limb Preservation | Recruiting |
| New Haven, Connecticut, United States, 06515 | |
| Contact 203-397-0624 | |
| United States, District of Columbia | |
| Georgetown University / Wound Healing Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact 202-444-1784 | |
| United States, Florida | |
| Doctor's Research Network | Recruiting |
| South Miami, Florida, United States, 33143 | |
| Contact 305-662-1444 | |
| United States, Iowa | |
| Medical Associates | Recruiting |
| Clinton, Iowa, United States, 52732 | |
| Contact 563-519-1871 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21215 | |
| Contact 410-601-5106 | |
| United States, Massachusetts | |
| Preston Family Building | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact 617-414-6840 | |
| United States, Michigan | |
| Foot Healthcare Associates, PC | Recruiting |
| Livonia, Michigan, United States, 48152 | |
| Contact 734-542-9305 | |
| United States, Pennsylvania | |
| St. Vincent Health Center Wound Clinic | Recruiting |
| Erie, Pennsylvania, United States, 16444 | |
| Contact 814-452-7878 | |
| Pivotal Clinical Research | Recruiting |
| Souderton, Pennsylvania, United States, 18964 | |
| Contact 215-723-7121 | |
| Warren General Hospital Wound Clinic | Recruiting |
| Warren, Pennsylvania, United States, 16365 | |
| Contact 814-723-3300 ext 2752 | |
| Martin Foot and Ankle | Recruiting |
| York, Pennsylvania, United States, 17403 | |
| Contact 717-718-0216 | |
| United States, Texas | |
| San Antonio Podiatry Associates, PC | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact 210-949-0807 | |
| United States, Utah | |
| Pharmaceutical Research Organization | Recruiting |
| Bountiful, Utah, United States, 84010 | |
| Contact 801-294-9911 | |
| Dixie Regional Medical Center's Wound Clinic | Recruiting |
| St. George, Utah, United States, 84770 | |
| Contact 435-688-5281 | |
| United States, Washington | |
| Central Washington Podiatry Service | Recruiting |
| Yakima, Washington, United States, 98902 | |
| Contact 509-248-2900 | |
Sponsors and Collaborators
KeraCure
More Information
No publications provided
| Responsible Party: | KeraCure |
| ClinicalTrials.gov Identifier: | NCT00330265 History of Changes |
| Other Study ID Numbers: | NCT 20051320 |
| Study First Received: | May 24, 2006 |
| Last Updated: | August 25, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ulcer Foot Ulcer Diabetic Foot Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on June 18, 2013