Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Not Applicable

Completed

• Conditions: Venous Ulcers
• Interventions: Procedure: Blood Draw

• Registration Number: NCT02034396
• Lead Sponsor: University of Pittsburgh

Brief Summary

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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Detailed Description

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood draw	Blood Draw	One blood draw at enrollment

Primary Outcome Measures

Name	Time	Method
Ulcer healing	Assessment made when batch of samples (360) obtained	Time to ulcer healing
Ulcer recurrence	Assessment made when batch of samples (360) obtained	Presence of ulcer recurrence

Secondary Outcome Measures

Name	Time	Method
Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence	Assessment made when batch of samples (360) obtained

Trial Locations

Locations (1)

UPMC Heart and Vascular Institute - Division of Vascular Surgery; 🇺🇸 Pittsburgh, Pennsylvania, United States