Clinical Implications of Genetic Variations of Venous Stasis Ulceration
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | May 2011 |
| End Date: | May 2020 |
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.
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.
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.
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.
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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15232
Principal Investigator: Rabih Chaer, MD
Phone: 412-623-8452
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