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Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Primary Purpose

Venous Ulcers

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Blood Draw

About this trial

This is an interventional screening trial for Venous Ulcers focused on measuring Ulcers, venous, unna's boot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UPMC Heart and Vascular Institute - Division of Vascular Surgery

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Blood draw

Arm Description

One blood draw at enrollment

Outcomes

Primary Outcome Measures

Ulcer healing

Time to ulcer healing

Ulcer recurrence

Presence of ulcer recurrence

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02034396

First Posted

January 2, 2014

Last Updated

May 6, 2022

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT02034396

Brief Title

Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Official Title

Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

May 2011 (Actual)

Primary Completion Date

March 31, 2022 (Actual)

Study Completion Date

March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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. .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Ulcers

Keywords

Ulcers, venous, unna's boot

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

377 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blood draw

Arm Type

Other

Arm Description

One blood draw at enrollment

Intervention Type

Procedure

Intervention Name(s)

Blood Draw

Intervention Description

One blood draw at enrollment

Primary Outcome Measure Information:

Title

Ulcer healing

Description

Time to ulcer healing

Time Frame