Venous Ulcers
Conditions
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
One blood draw at enrollment
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence | Assessment made when batch of samples (360) obtained |
Other
| Measure | Time frame |
|---|---|
| Analysis of association between clinical variables and genetic testing results | Assessment made when batch of samples (360) obtained |
| Analysis of clinical variables in conjunction with ulcer healing and recurrence | Assessment made when batch of samples (360) obtained |
Countries
United States