NCT00512538

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2000

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
Last Updated

August 7, 2007

Status Verified

August 1, 2007

First QC Date

August 3, 2007

Last Update Submit

August 3, 2007

Conditions

Diabetic Foot

Keywords

Diabetic foot

Outcome Measures

Primary Outcomes (1)

  • Time to complete wound healing (full epithelialization with no drainage)

    through 12 weeks

Secondary Outcomes (1)

  • Incidence of complete healing

    at 12 weeks

Interventions

Bi-layered cell therapy (Apligraf)DEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Michael E Edmonds, MD

    Diabetic Foot Clinic, Kings College Hospital, London UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 7, 2007

Study Start

October 1, 2000

Study Completion

September 1, 2002

Last Updated

August 7, 2007

Record last verified: 2007-08