Clinical Implications of Genetic Variations of Venous Stasis Ulceration

NCT ID: NCT02034396

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 377 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2022-03-31

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.

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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.

Conditions

Venous Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Blood draw

One blood draw at enrollment

Group Type: OTHER

Blood Draw

Intervention Type: PROCEDURE

One blood draw at enrollment

Interventions

Blood Draw

One blood draw at enrollment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• >/=18y.o.
• active venous ulcer (CEAP 6)
• healed venous ulcer (CEAP 5)

• >/= 50y.o.
• no reported clinical symptoms of venous disease
• (CEAP 0 or 1)

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

• <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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Rabih A. Chaer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabih Chaer, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC/UPP Vascular Surgery

Locations

UPMC Heart and Vascular Institute - Division of Vascular Surgery

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO10120155

Identifier Type: -

Identifier Source: org_study_id