Clinical Implications of Genetic Variations of Venous Stasis Ulceration

University of Pittsburgh

Status

Completed

Conditions

Venous Ulcers

Treatments

Procedure: Blood Draw

Study type

Interventional

Funder types

Other

Identifiers

NCT02034396

PRO10120155

Details and patient eligibility

About

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.

Full 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.

Enrollment

377 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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