Venous UlcersNCT02034396
Clinical Implications of Genetic Variations of Venous Stasis Ulceration
A study testing Blood Draw in people with Venous Ulcers, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Ulcers
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >/=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)
Who cannot join
- <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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Heart and Vascular Institute - Division of Vascular Surgery
Pittsburgh, Pennsylvania, 15232
About this study
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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Read the 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
- Being tested
- Blood Draw
- Keywords
- Ulcers, venous, unna's boot
- Medical subject headings
- Varicose Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
One blood draw at enrollment
| Study group | Role | What they receive |
|---|---|---|
| Blood draw | Other | One blood draw at enrollment Receives: Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer healing
Time to ulcer healing
Measured: Assessment made when batch of samples (360) obtained
Ulcer recurrence
Presence of ulcer recurrence
Measured: 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
Measured: Assessment made when batch of samples (360) obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startMay 2011
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabih A. Chaer, University of Pittsburgh
- Investigators
- Rabih Chaer, MD, Principal investigator, UPMC/UPP Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034396
- Sponsor's protocol ID
- PRO10120155
- Status last verified
- May 2022
- First submitted
- 2 Jan 2014
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implications of Genetic Variations of Venous Stasis Ulceration
- ClinicalTrials.gov ID
- NCT02034396
- Acronym / sponsor ID
- PRO10120155
- Conditions
- Venous Ulcers
- Keywords
- Ulcers, venous, unna's boot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood draw | Other | Procedure: Blood DrawOne blood draw at enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >/=18y.o.
- active venous ulcer (CEAP 6)
- healed venous ulcer (CEAP 5)
- >/= 50y.o.
- no reported clinical symptoms of venous disease
Key exclusion criteria (13 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawOne blood draw at enrollment | Procedure or surgery | Blood draw |
Primary outcome
Ulcer healing
Time frame: Assessment made when batch of samples (360) obtained
Time to ulcer healing
Ulcer recurrence
Time frame: Assessment made when batch of samples (360) obtained
Presence of ulcer recurrence
1 secondary outcome
Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence
Time frame: Assessment made when batch of samples (360) obtained
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabih Chaer, MD principal investigator
UPMC/UPP Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Draw in people with Venous Ulcers, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer healing (time frame: Assessment made when batch of samples (360) obtained). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.