Venous InsufficiencyNCT01680809
Compliance of Compression Therapy in Healed Venous Ulcerations
A study testing Compression stocking 15-20mmHg and Compression stocking 20-30mmHg in people with Venous Insufficiency, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
This study seeks to determine if compliance with compression therapy is increased in patients with healed venous insufficiency ulcerations when lower levels of compression therapy are prescribed. This study will measure compliance with compression therapy at low levels of compression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Compression stocking 15-20mmHg and Compression stocking 20-30mmHg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently healed venous insufficiency ulcerations
- History of venous insufficiency
- Patient from UH Richmond Wound Care Center (recently discharged/healed venous ulcerations)
Who cannot join
- Children
- Patients with diagnosed arterial insufficiency or ABI less than 0.5
- Patients that are diagnosed with Congestive Heart Failure and not cardiac cleared
- Patients with paralysis or incapacitated physically or mentally (due to inability to apply compression stockings)
Trial locations and contacts
1 site in 1 country.
United States1 site
Richmond Medical Center (University Hospitals of Cleveland)
Richmond Heights, Ohio, 44143
About this study
This study seeks to determine if compliance with compression therapy is increased in patients with healed venous insufficiency ulcerations when lower levels of compression therapy are prescribed. This study will measure compliance with compression therapy at low levels of compression. It will also seek to determine if compression therapy aids in the prevention of venous insufficiency ulcer recurrence.
Read the detailed description
This study looks to determine if patients with a history of venous insufficiency and recently healed venous insufficiency ulcerations are compliant with lower levels of compression therapy. It also seeks to evaluate the efficacy of compression therapy in the prevention of recurrence of venous insufficiency ulcerations.
- Conditions
- Venous Insufficiency
- Being tested
- Compression stocking 15-20mmHg, Compression stocking 20-30mmHg
- Keywords
- Venous insufficiency, Venous stasis ulcerations, Compression stockings, Compression stocking compliance
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression stocking 15-20mmHgDevice
Compression stocking with 15-20mmHg of compression
Compression stocking 20-30mmHgDevice
Compression stocking with 20-30mmHg of compression
| Study group | Role | What they receive |
|---|---|---|
| Compression stocking 15-20mmHg | Experimental | Compression stocking 15-20mmHg Receives: Device: Compression stocking 15-20mmHg |
| Compression stocking 20-30mmHg | Experimental | Compression stocking 20-30mmHg Receives: Device: Compression stocking 20-30mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of Compression Therapy
Patients will be assessed for compliance of compression therapy at the following intervals (1 month, 3 months, 6 months, 9 months, and 12 months) -- this will be accomplished via patient questionnaire/interview at scheduled appointments at each stated interval.
Measured: 12 months
Secondary outcomes (1)
Ulceration recurrence
We will evaluate if venous ulcerations have recurred with compression therapy over the course of 12 months. The patient will be seen/evaluated at appointments scheduled at 1 month, 3 months, 6 months, 9 months and 12 months. At each visit, the patient will be evaluated for recurrence of ulcerations. If ulceration recurs, then the patient will be removed from the study and be eligible for treatment of ulcerations.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole E Allen-Wilson, DPM, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680809
- Sponsor's protocol ID
- CWCT-001
- Status last verified
- May 2022
- First submitted
- 31 Aug 2012
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Milic DJ, Zivic SS, Bogdanovic DC, Karanovic ND, Golubovic ZV. Risk factors related to the failure of venous leg ulcers to heal with compression treatment. J Vasc Surg. 2009 May;49(5):1242-7. doi: 10.1016/j.jvs.2008.11.069. Epub 2009 Feb 23.
PubMed 19233601Gillespie DL; Writing Group III of the Pacific Vascular Symposium 6; Kistner B, Glass C, Bailey B, Chopra A, Ennis B, Marston B, Masuda E, Moneta G, Nelzen O, Raffetto J, Raju S, Vedantham S, Wright D, Falanga V. Venous ulcer diagnosis, treatment, and prevention of recurrences. J Vasc Surg. 2010 Nov;52(5 Suppl):8S-14S. doi: 10.1016/j.jvs.2010.05.068. Epub 2010 Aug 3. No abstract available.
PubMed 20678885Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. J Vasc Surg. 1999 Sep;30(3):491-8. doi: 10.1016/s0741-5214(99)70076-5.
PubMed 10477642Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8. doi: 10.1016/j.jvs.2006.05.051.
PubMed 17012004Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
PubMed 15183623Baranoski S, Ayello EA. Wound Care Essentials: Practice Principles, 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins, 2011. Print.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance of Compression Therapy in Healed Venous Ulcerations
- ClinicalTrials.gov ID
- NCT01680809
- Acronym / sponsor ID
- CWCT-001
- Conditions
- Venous Insufficiency
- Keywords
- Venous insufficiency, Venous stasis ulcerations, Compression stockings, Compression stocking compliance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 7 Sep 2012 (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.
This study seeks to determine if compliance with compression therapy is increased in patients with healed venous insufficiency ulcerations when lower levels of compression therapy are prescribed. This study will measure compliance with compression therapy at low levels of compression. It will also seek to determine if compression therapy aids in the prevention of venous insufficiency ulcer recurrence.
Detailed description
This study looks to determine if patients with a history of venous insufficiency and recently healed venous insufficiency ulcerations are compliant with lower levels of compression therapy. It also seeks to evaluate the efficacy of compression therapy in the prevention of recurrence of venous insufficiency ulcerations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression stocking 15-20mmHg | Experimental | Device: Compression stocking 15-20mmHgCompression stocking 15-20mmHg |
| Compression stocking 20-30mmHg | Experimental | Device: Compression stocking 20-30mmHgCompression stocking 20-30mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recently healed venous insufficiency ulcerations
- History of venous insufficiency
- Patient from UH Richmond Wound Care Center (recently discharged/healed venous ulcerations)
Key exclusion criteria (4 listed)
- Children
- Patients with diagnosed arterial insufficiency or ABI less than 0.5
- Patients that are diagnosed with Congestive Heart Failure and not cardiac cleared
- Patients with paralysis or incapacitated physically or mentally (due to inability to apply compression stockings)
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 |
|---|---|---|
| Compression stocking 15-20mmHgCompression stocking with 15-20mmHg of compression | Device | Compression stocking 15-20mmHg |
| Compression stocking 20-30mmHgCompression stocking with 20-30mmHg of compression | Device | Compression stocking 20-30mmHg |
Primary outcome
Compliance of Compression Therapy
Time frame: 12 months
Patients will be assessed for compliance of compression therapy at the following intervals (1 month, 3 months, 6 months, 9 months, and 12 months) -- this will be accomplished via patient questionnaire/interview at scheduled appointments at each stated interval.
1 secondary outcome
Ulceration recurrence
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 19233601Milic DJ, Zivic SS, Bogdanovic DC, Karanovic ND, Golubovic ZV. Risk factors related to the failure of venous leg ulcers to heal with compression treatment. J Vasc Surg. 2009 May;49(5):1242-7. doi: 10.1016/j.jvs.2008.11.069. Epub 2009 Feb 23.
- Background: PubMed 20678885Gillespie DL; Writing Group III of the Pacific Vascular Symposium 6; Kistner B, Glass C, Bailey B, Chopra A, Ennis B, Marston B, Masuda E, Moneta G, Nelzen O, Raffetto J, Raju S, Vedantham S, Wright D, Falanga V. Venous ulcer diagnosis, treatment, and prevention of recurrences. J Vasc Surg. 2010 Nov;52(5 Suppl):8S-14S. doi: 10.1016/j.jvs.2010.05.068. Epub 2010 Aug 3. No abstract available.
- Background: PubMed 10477642Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. J Vasc Surg. 1999 Sep;30(3):491-8. doi: 10.1016/s0741-5214(99)70076-5.
- Background: PubMed 17012004Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8. doi: 10.1016/j.jvs.2006.05.051.
- Background: PubMed 15183623Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
- BackgroundBaranoski S, Ayello EA. Wound Care Essentials: Practice Principles, 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins, 2011. Print.
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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.
Nicole E Allen-Wilson, DPM principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression stocking 15-20mmHg and Compression stocking 20-30mmHg in people with Venous Insufficiency, run by University Hospitals Cleveland Medical Center 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 17 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 was withdrawn before enrolling participants, so there are no results.
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?
Compliance of Compression Therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01680809, which also lists 6 linked publications.
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 17 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.