Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

Diabetic Foot Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00512538
• Other study ID #: CGS0769 B304
• Status: Terminated
• Phase: Phase 3
• First received: August 3, 2007
• Last updated: August 3, 2007
• Start date: October 2000
• Est. completion date: September 2002

Study information

• Verified date: August 2007
• Source: Organogenesis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines Control Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Device:
• Bi-layered cell therapy (Apligraf)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organogenesis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete wound healing (full epithelialization with no drainage)		through 12 weeks
Secondary	Incidence of complete healing		at 12 weeks