Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Study Overview
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Brief Summary
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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. .

Detailed Description
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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.

Official Title
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Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Conditions
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Venous Ulcers

Intervention / Treatment
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* Procedure: Blood Draw


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Blood draw<br>One blood draw at enrollment | Procedure: Blood Draw<br>* One blood draw at enrollment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer healing | Time to ulcer healing | Assessment made when batch of samples (360) obtained | 
| Ulcer recurrence | Presence of ulcer recurrence | Assessment made when batch of samples (360) obtained | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence |  | Assessment made when batch of samples (360) obtained | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcers, venous, unna's boot