Clinical trial NCT00330265: Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Foot Ulcer
Diabetes
Lead sponsor: KeraCure
Sponsor class: INDUSTRY
First posted: 2006-05-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Institute for Advanced Wound Care at Baptist Medical Center South
state: Alabama
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Fresno
country: United States
facility: Roy Kroeker, DPM
state: California
city: Los Angeles
country: United States
facility: Felix Sigal, DPM
state: California
city: San Francisco
country: United States
facility: Bay Area Foot Care
state: California
city: New Haven
country: United States
facility: North American Center for Limb Preservation
state: Connecticut
city: Washington
country: United States
facility: Georgetown University / Wound Healing Center
state: District of Columbia
city: South Miami
country: United States
facility: Doctor's Research Network
state: Florida
city: Clinton
country: United States
facility: Medical Associates
state: Iowa
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Boston
country: United States
facility: Preston Family Building
state: Massachusetts
city: Livonia
country: United States
facility: Foot Healthcare Associates, PC
state: Michigan
city: Erie
country: United States
facility: St. Vincent Health Center Wound Clinic
state: Pennsylvania
city: Souderton
country: United States
facility: Pivotal Clinical Research
state: Pennsylvania
city: Warren
country: United States
facility: Warren General Hospital Wound Clinic
state: Pennsylvania
city: York
country: United States
facility: Martin Foot and Ankle
state: Pennsylvania
city: San Antonio
country: United States
facility: San Antonio Podiatry Associates, PC
state: Texas
city: Bountiful
country: United States
facility: Pharmaceutical Research Organization
state: Utah
city: St. George
country: United States
facility: Dixie Regional Medical Center's Wound Clinic
state: Utah
city: Yakima
country: United States
facility: Central Washington Podiatry Service
state: Washington
Study officials:
References: