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OpenTrials
Completed

NCT Number: NCT02034396

Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Currently, there is no standard approach for the treatment of patients with venous stasis ulcers, and no means of accounting for the genetic factors that may contribute to a patient's response to different therapeutic interventions. In order to determine whether, or to what extent, genetic profiling of venous stasis ulcers can stratify patients according to their potential for disease progression or healing, and guide preventive strategies and levels of therapeutic interventions, the study will involve retrospective genetic profiling of patients with a healed or persistent venous stasis ulcer as a means of determining the efficacy of current therapies, and to establish a future prospective evaluation of treatment algorithms based on genetic phenotype and variation. Results obtained from the 2 aforementioned groups of participants will be compared with those of a control group of participants who have no history of venous ulcer nor peripheral vascular disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Heart and Vascular Institute - Division of Vascular Surgery

Pittsburgh, Pennsylvania, 15232, United States

About this study

A blood specimen will be drawn, medical and medication history taken, and wound/s will be assessed and followed for 2 years in regard to the enrollees w/active venous ulcer/s or healed venous ulcer/s.

A venous duplex ultrasound of right and left lower extremities will be done at no cost, a blood specimen will be drawn, and medical and medication history will be taken in regard to control group enrollees.

Who can participate

Healthy volunteers accepted: Yes

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

Group 1-Active venous ulcer (CEAP 6) & Group 2-Healed venous ulcer (CEAP 5)

Inclusion criteria

  • >/=18y.o.
  • active venous ulcer (CEAP 6)
  • healed venous ulcer (CEAP 5)

Exclusion criteria

  • <18 y.o.
  • inability to comply w/compression therapy
  • Inability to maintain f/u schedule
  • ABI (ankle-brachial index) < 0.5 if pedal pulses are not palpable
  • Inability to ambulate w/active ulcer (N/A for Group 2)
  • Diabetic w/ABI <0.5
  • Severe premorbid systemic disease such as pulmonary failure, heart failure, renal failure, or hepatic failure w/a life expectancy of <1 year
  • Chronic steroid therapy Group 3-Controls

Inclusion criteria

  • >/= 50y.o.
  • no reported clinical symptoms of venous disease
  • (CEAP 0 or 1)

Exclusion criteria

  • <50y.o.
  • ABI (ankle-brachial index) < 0.5 if pedal pulses are not palpable
  • Diabetic w/ABI < 0.5
  • Severe premorbid systemic disease such as pulmonary failure, heart failure, renal failure, or hepatic failure w/a life expectancy of <1 year
  • Chronic steroid therapy

Treatment and study plan

Blood draw

Procedure

One blood draw at enrollment

Primary outcomes

  1. Ulcer healing

    Time frame: Assessment made when batch of samples (360) obtained

    Time to ulcer healing

  2. Ulcer recurrence

    Time frame: Assessment made when batch of samples (360) obtained

    Presence of ulcer recurrence

Secondary outcomes

  1. Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence

    Time frame: Assessment made when batch of samples (360) obtained

Other outcomes

  1. Analysis of association between clinical variables and genetic testing results

    Time frame: Assessment made when batch of samples (360) obtained

  2. Analysis of clinical variables in conjunction with ulcer healing and recurrence

    Time frame: Assessment made when batch of samples (360) obtained

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2014
Registry last updated
May 9, 2022

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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