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Completed

NCT Number: NCT01891760

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

* 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)

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

East-Tallinn Central Hospital Department of Rheumatology, Tallinn, Estonia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dermagraft

Device

Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).

Profore

Device

Four-layer compression bandaging therapy.

Primary outcomes

  1. The incidence of study ulcer recurrence

    Time frame: 1 year

Secondary outcomes

  1. Incidence of complete study ulcer healing

    Time frame: 1 year

  2. Incidence of study ulcer infection-related events

    Time frame: 1 year

  3. Time to study ulcer recurrence

    Time frame: 1 year

  4. Change in ulcer size

    Time frame: 1 year

  5. Time to study ulcer healing

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Shire Regenerative Medicine, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial

Acronym: LTFU

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 3, 2013
Registry last updated
Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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