Clinical trial NCT02034396: Clinical Implications of Genetic Variations of Venous Stasis Ulceration
Official title: Clinical Implications of Genetic Variations of Venous Stasis Ulceration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcers
Keywords: Ulcers, venous, unna's boot
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

.

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.

Eligibility 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

Primary outcomes:
measure: Ulcer healing
timeFrame: Assessment made when batch of samples (360) obtained
measure: Ulcer recurrence
timeFrame: Assessment made when batch of samples (360) obtained
Secondary outcomes:
measure: Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence
timeFrame: Assessment made when batch of samples (360) obtained
Other outcomes:
measure: Analysis of association between clinical variables and genetic testing results
timeFrame: Assessment made when batch of samples (360) obtained
measure: Analysis of clinical variables in conjunction with ulcer healing and recurrence
timeFrame: Assessment made when batch of samples (360) obtained
Locations:
city: Pittsburgh
country: United States
facility: UPMC Heart and Vascular Institute - Division of Vascular Surgery
state: Pennsylvania
Study officials:
affiliation: UPMC/UPP Vascular Surgery
name: Rabih Chaer, MD
role: PRINCIPAL_INVESTIGATOR
References: