Clinical Implications of Genetic Variations of Venous Stasis Ulceration

NCT02034396 | Completed DMC

• 1 other identifier: PRO10120155
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

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. .

Conditions

Venous Ulcers

Keywords

Ulcers, venous, unna's boot

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence

  Assessment made when batch of samples (360) obtained

Other Outcomes (2)

• 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

Study Arms (1)

Blood draw

OTHER

One blood draw at enrollment

Procedure: Blood Draw

Interventions

Blood Draw PROCEDURE

One blood draw at enrollment

Blood draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<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.
• no reported clinical symptoms of venous disease
• (CEAP 0 or 1)
• \<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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Heart and Vascular Institute - Division of Vascular Surgery

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rabih Chaer, MD

  UPMC/UPP Vascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 13, 2014
• Study Start: May 1, 2011
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

US (1)