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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood draw | Other | One blood draw at enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Procedure | One blood draw at enrollment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer healing | Time to ulcer healing | Assessment made when batch of samples (360) obtained |
| Ulcer recurrence | Presence of ulcer recurrence | Assessment made when batch of samples (360) obtained |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence | Assessment made when batch of samples (360) obtained |
| Measure | Description | 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 |
Group 1-Active venous ulcer (CEAP 6) & Group 2-Healed venous ulcer (CEAP 5)
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rabih Chaer, MD | UPMC/UPP Vascular Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Heart and Vascular Institute - Division of Vascular Surgery | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |