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Clinical Implications of Genetic Variations of Venous Stasis Ulceration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034396
Recruitment Status : Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Rabih A. Chaer, University of Pittsburgh

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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Condition or disease Intervention/treatment Phase
Venous Ulcers Procedure: Blood Draw Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Clinical Implications of Genetic Variations of Venous Stasis Ulceration
Actual Study Start Date : May 2011
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Blood draw
One blood draw at enrollment
Procedure: Blood Draw
One blood draw at enrollment




Primary Outcome Measures :
  1. Ulcer healing [ Time Frame: Assessment made when batch of samples (360) obtained ]
    Time to ulcer healing

  2. Ulcer recurrence [ Time Frame: Assessment made when batch of samples (360) obtained ]
    Presence of ulcer recurrence


Secondary Outcome Measures :
  1. Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence [ Time Frame: Assessment made when batch of samples (360) obtained ]

Other Outcome Measures:
  1. Analysis of association between clinical variables and genetic testing results [ Time Frame: Assessment made when batch of samples (360) obtained ]
  2. Analysis of clinical variables in conjunction with ulcer healing and recurrence [ Time Frame: Assessment made when batch of samples (360) obtained ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034396


Locations
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United States, Pennsylvania
UPMC Heart and Vascular Institute - Division of Vascular Surgery
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Rabih Chaer, MD UPMC/UPP Vascular Surgery
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Responsible Party: Rabih A. Chaer, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02034396    
Other Study ID Numbers: PRO10120155
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Keywords provided by Rabih A. Chaer, University of Pittsburgh:
Ulcers, venous, unna's boot
Additional relevant MeSH terms:
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Varicose Ulcer
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases