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Completed

NCT Number: NCT00900029

Safety Follow-Up to HP 802-247-09-015

This is a 24-week observational follow safety study for Study 802-247-09-015.

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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 Venous Stasis Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aging Rehabilitation & Geriatric Care Research Center, London, Ontario, Canada

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About this study

The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provide informed consent
  • Willing to comply with protocol instructions, including allowing all study assessments.
  • Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo.
  • Subject has ended their participation in HP 802-247-09-015 by virtue of completing the study, or by dropping out prior to completion.

Exclusion criteria

  • Subjects who refuse to provide written informed consent will be excluded from this trial.

Treatment and study plan

No HP802 Treatment

Biological

No HP802 Vehicle Treatment

Other

Primary outcomes

  1. The Number of Participants With Closed Target Ulcers at Each Visit

    Time frame: Over the 24-week study period, at each of the bi-monthly visits

    At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.

  2. Number of Subjects With Target Wound Closed for the First Time During the Study Period.

    Time frame: Over the 24-week study period, at each of the bi-monthly visits

    At each visit the status of open target ulcers was evaluated as "remained open" or "closed".

Sponsors and collaborators

Lead sponsor

Healthpoint

Industry

Registry information

Official study title

A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
May 12, 2009
Registry last updated
Aug 2, 2017

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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