Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers - Full Text View

Sponsored by:	Organogenesis
Information provided by:	Organogenesis
ClinicalTrials.gov Identifier:	NCT00512538

Purpose

The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.

Condition	Intervention	Phase
Diabetic Foot	Device: Bi-layered cell therapy (Apligraf)	Phase III

MedlinePlus related topics: Diabetic Foot Foot Health

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Multi-Center Study to Compare the Safety and Efficacy of Apligraf Versus Standard Therapy (i.e., Saline Moistened Dressing Regimen) in the Treatment of Diabetic (Primarily Neuropathic) Foot Ulcers

Further study details as provided by Organogenesis:

Primary Outcome Measures:

Time to complete wound healing (full epithelialization with no drainage) [ Time Frame: through 12 weeks ]

Secondary Outcome Measures:

Incidence of complete healing [ Time Frame: at 12 weeks ]

Enrollment:	82
Study Start Date:	October 2000
Study Completion Date:	September 2002

Detailed Description:

Ulceration of the diabetic foot is a result of multiple problems including repetitive stress on a neuropathic or insensate area that is often associated with an underlying bony prominence. By healing diabetic foot ulcers quickly the risks of infection, osteomyelitis (infeciton of the bone) and limb loss can be reduced.

This study will evaluate the ability of Apligraf to heal diabetic foot ulcers that have been present for at least 2 weeks and are between 1 - 16 cm2 in area. Patients will be randomized to either (50:50 chance) treatment with Apligraf or a saline moistened dressing regimen (standard therapy). All patients will receive standard cares for the ulcers which includes debridement, orthotics and off-loading throughout the treatment period.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot
ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure
ulcer present for at least 2 weeks and measuring 1- 16 cm2
diminished sensesation on target extremity/foot
ulcer is not infected
Type 1 or 2 diabetes with adequate glycemic control
Adequate vascular supply to the target extremity

Exclusion Criteria:

Charcot foot
Non-neuropathic ulcers
Skin cancer within or adjacent to the target ulcer
Osteomyelitis or an infected ulcer
Clinically significant medical condition that would impair wound healing
Females who are pregnant
Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512538

Sponsors and Collaborators

Organogenesis

Investigators

Principal Investigator:

Michael E Edmonds, MD

Diabetic Foot Clinic, Kings College Hospital, London UK

More Information

Study ID Numbers:	CGS0769 B304
Study First Received:	August 3, 2007
Last Updated:	August 3, 2007
ClinicalTrials.gov Identifier:	NCT00512538
Health Authority:	United Kingdom: Research Ethics Committee; United Kingdom: Medicines Control Agency

Keywords provided by Organogenesis:

Diabetic foot

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009