Leg UlcerNCT03725111
Haemodynamics Variations of Transcutaneous Oxygen in Patient With Areterio-venous Leg Ulcers Under Venous Compression
A study testing venous compression in people with Leg Ulcer and Compression; Vein, run by University Hospital, Caen at 1 site in France.
Trial summary
Arterio-venous leg ulcers are real problems when it comes to public health because it has a major cost and leads to social and professional handicap. The management of leg ulcers is not clear and can be venous compression or surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leg Ulcer, Compression; Vein
- What is being tested?
- venous compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2018to 31 Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age eighteen or more
- leg arteio-venous ulcers
Who cannot join
- age Under eighteen,
- Index pressure in the ankle Under 0.5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haemodynamics Variations of Transcutaneous Oxygen in Patient With Arterio-venous Leg Ulcers Under Venous Compression (COMPULCE Study)
Arterio-venous leg ulcers are real problems when it comes to public health because it has a major cost and leads to social and professional handicap.
The management of leg ulcers is not clear and can be venous compression or surgery.
The aim of the study is to evaluate the variation of the transcutaneous oxygen with compression.
The second aim is to see how tolerate is the compression and the quality of life.
- Conditions
- Leg Ulcer, Compression; Vein
- Being tested
- venous compression
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous compressionDevice
venous compression
| Study group | Role | What they receive |
|---|---|---|
| arterio venous leg ulcers | Experimental | Not described Receives: Device: venous compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
haemodynamic variation of the transcutaneous oxygen
measurement of the transcutaneous oxygen during two different appointement using a transcutaneous monitor TCM4
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start30 Dec 2018
- Primary completion31 Dec 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725111
- Sponsor's protocol ID
- 2018-A01048-47
- Status last verified
- Nov 2018
- First submitted
- 19 Oct 2018
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elhomsy S, Chrusciel J, Sanchez S, Elhomsy P, Guillaumat J. Clinical Efficacy and Safety of Long-Term Compression in Patients with Mixed Arterial and Venous Etiology Ulcers in the Leg. Int J Angiol. 2021 Aug 31;31(1):34-39. doi: 10.1055/s-0041-1735204. eCollection 2022 Mar.
PubMed 35221850
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamics Variations of Transcutaneous Oxygen in Patient With Arterio-venous Leg Ulcers Under Venous Compression (COMPULCE Study)
- ClinicalTrials.gov ID
- NCT03725111
- Acronym / sponsor ID
- 2018-A01048-47
- Conditions
- Leg Ulcer, Compression; Vein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Dec 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 30 Oct 2018 (actual)
- 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.
Arterio-venous leg ulcers are real problems when it comes to public health because it has a major cost and leads to social and professional handicap.
The management of leg ulcers is not clear and can be venous compression or surgery.
The aim of the study is to evaluate the variation of the transcutaneous oxygen with compression.
The second aim is to see how tolerate is the compression and the quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arterio venous leg ulcers | Experimental | Device: venous compression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age eighteen or more
- leg arteio-venous ulcers
Key exclusion criteria (2 listed)
- age Under eighteen,
- Index pressure in the ankle Under 0.5
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 |
|---|---|---|
| venous compressionvenous compression | Device | arterio venous leg ulcers |
Primary outcome
haemodynamic variation of the transcutaneous oxygen
Time frame: 1 month
measurement of the transcutaneous oxygen during two different appointement using a transcutaneous monitor TCM4
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 17 Feb 2026.
- Results publication: PubMed 35221850Elhomsy S, Chrusciel J, Sanchez S, Elhomsy P, Guillaumat J. Clinical Efficacy and Safety of Long-Term Compression in Patients with Mixed Arterial and Venous Etiology Ulcers in the Leg. Int J Angiol. 2021 Aug 31;31(1):34-39. doi: 10.1055/s-0041-1735204. eCollection 2022 Mar.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venous compression in people with Leg Ulcer and Compression; Vein, run by University Hospital, Caen at 1 site in France.
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 2 inclusion and 2 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 17 Feb 2026. 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 France. 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?
haemodynamic variation of the transcutaneous oxygen (time frame: 1 month). 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 NCT03725111, which also lists 1 linked publication.
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 Feb 2026.