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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00512538

Enrollment

Registered

2007-08-07

Start date

2000-10-31

Completion date

2002-09-30

Last updated

2007-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Keywords

Diabetic foot

Brief 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.

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.

Interventions

DEVICEBi-layered cell therapy (Apligraf)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to complete wound healing (full epithelialization with no drainage)	through 12 weeks

Secondary

Measure	Time frame
Incidence of complete healing	at 12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026