Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

This study has been terminated.
(Interruption of business relations between Study Sponsor and Device Manufacturer)
Sponsor:
Information provided by:
Organogenesis
ClinicalTrials.gov Identifier:
NCT00512538
First received: August 3, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

August 3, 2007
August 3, 2007
October 2000
Not Provided
Time to complete wound healing (full epithelialization with no drainage) [ Time Frame: through 12 weeks ]
Same as current
No Changes Posted
Incidence of complete healing [ Time Frame: at 12 weeks ]
Same as current
Not Provided
Not Provided
 
Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Foot
Device: Bi-layered cell therapy (Apligraf)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
82
September 2002
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00512538
CGS0769 B304
No
Not Provided
Organogenesis
Not Provided
Principal Investigator: Michael E Edmonds, MD Diabetic Foot Clinic, Kings College Hospital, London UK
Organogenesis
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP