Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

Phase 3

Completed

• Conditions: Venous Leg Ulcer

• Registration Number: NCT01891760
• Lead Sponsor: Shire Regenerative Medicine, Inc.

Brief Summary

* Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study.

* Study Hypothesis: N/A (Long-term follow-up study)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-03
• Disposition First Submitted: 2013-07-15
• Disposition First Submitted QC: 2013-07-15
• Disposition First Posted: 2013-07-17
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

1. Subject has completed study ABH-Dermagraft-001-08
2. Subject understands study requirements
3. Subject is available to participate in the 1 year-long observational follow-up.

Exclusion Criteria

1. Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion
2. Subject is not available for the 1 year-long observational period.
3. Subject has any condition(s) which seriously compromises the subject's ability to complete the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of study ulcer recurrence	1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of complete study ulcer healing	1 year
Incidence of study ulcer infection-related events	1 year
Time to study ulcer recurrence	1 year
Change in ulcer size	1 year
Time to study ulcer healing	1 year

Trial Locations

Locations (28)

Carl T. Hayden VA Medical Center; 🇺🇸 Phoenix, Arizona, United States

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

Dr. Jagpreet S. Mukker; 🇺🇸 Fresno, California, United States

VA Northern California Health Care Sytem; 🇺🇸 Mather, California, United States

North Amercian Center for Limb Preservation; 🇺🇸 New Haven, Connecticut, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Doctor's Research Network; 🇺🇸 South Miami, Florida, United States

South Florida Wound Care Group, P.A.; 🇺🇸 Tamarac, Florida, United States

Covenant Wound Healing Center; 🇺🇸 Saginaw, Michigan, United States

Advanced Foot & Ankle Center; 🇺🇸 Las Vegas, Nevada, United States

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