Text Size

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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Organogenesis:
Diabetic foot

Additional relevant MeSH terms:
Foot Ulcer
Diabetic Foot
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 May 16, 2013