Clinical trial NCT00399308: Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
Official title: An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leg Ulcer
Varicose Ulcer
Keywords: wound
leg
venous
chronic
wound healing
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.

Detailed description: Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.

Eligibility criteria: Inclusion Criteria:

* venous ulcer \> 1 month and \< 12 months in duration; 2 to 20 sq cm in surface area; not infected
* confirmatory venous ultrasound showing prior DVT and concurrent venous reflux
* ankle-brachial index 0.80 or greater

Exclusion Criteria:

* cutaneous malignancy
* recent treatment with corticosteroids or chemotherapeutic agents
* wound exposed bone, tendon or neurovascular structure
* wound infected and requiring antibiotics

Primary outcomes:
measure: Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.
timeFrame: 12 weeks
Secondary outcomes:
measure: Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.
timeFrame: 12 Weeks
measure: Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.
timeFrame: Variable - minimum of 12 weeks of follow-up.
measure: Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tamarac
country: United States
facility: Dr. Robert Snyder
state: Florida
city: Niles
country: United States
facility: National Center for Limb Preservation
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Division of Podiatry
state: Massachusetts
city: Bronx
country: United States
facility: Center for Curative & Palliative Wound Care, Calvary Hospital
state: New York
city: Stony Brook
country: United States
facility: State University of New York Stony Brook
state: New York
city: Durham
country: United States
facility: University of North Carolina at Chapel Hill, Division of Vascular Surgery
state: North Carolina
city: Altoona
country: United States
facility: Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic
state: Pennsylvania
city: San Antonio
country: United States
facility: Peripheral Vascular Associates, P.A.
state: Texas
city: Saint George
country: United States
facility: Dixie Regional Medical Center, Wound Care
state: Utah
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: