Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Venous Ulcers Clinical Trial

Official title:

Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034396
• Other study ID #: PRO10120155
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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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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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Ulcer
• Venous Ulcers

Intervention

Procedure:
• Blood Draw
One blood draw at enrollment

Locations

Country	Name	City	State
United States	UPMC Heart and Vascular Institute - Division of Vascular Surgery	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of association between clinical variables and genetic testing results		Assessment made when batch of samples (360) obtained
Other	Analysis of clinical variables in conjunction with ulcer healing and recurrence		Assessment made when batch of samples (360) obtained
Primary	Ulcer healing	Time to ulcer healing	Assessment made when batch of samples (360) obtained
Primary	Ulcer recurrence	Presence of ulcer recurrence	Assessment made when batch of samples (360) obtained
Secondary	Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence		Assessment made when batch of samples (360) obtained