Clinical Implications of Genetic Variations of Venous Stasis Ulceration

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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Study Overview

• Status: Completed
• Conditions: Venous Ulcers
• Intervention / Treatment: Procedure: Blood Draw

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.

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Heart and Vascular Institute - Division of Vascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood draw; One blood draw at enrollment	Procedure: Blood Draw; One blood draw at enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Rabih Chaer, MD, UPMC/UPP Vascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: January 2, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Ulcers, venous, unna's boot
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Varicose Ulcer
• Other Study ID Numbers: PRO10120155