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Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02034396
Enrollment
377
Registered
2014-01-13
Start date
2011-05-31
Completion date
2022-03-31
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Ulcers

Keywords

Ulcers, venous, unna's boot

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.

Interventions

PROCEDUREBlood Draw

One blood draw at enrollment

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Ulcer healingAssessment made when batch of samples (360) obtainedTime to ulcer healing
Ulcer recurrenceAssessment made when batch of samples (360) obtainedPresence of ulcer recurrence

Secondary

MeasureTime frame
Analysis of genetic variation in concert with ulcer healing, time to healing and recurrenceAssessment made when batch of samples (360) obtained

Other

MeasureTime frame
Analysis of association between clinical variables and genetic testing resultsAssessment made when batch of samples (360) obtained
Analysis of clinical variables in conjunction with ulcer healing and recurrenceAssessment made when batch of samples (360) obtained

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026