Venous UlcerCOMPARACHILLENCT04046120
Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers
A study testing Heel-free bandage in people with Venous Ulcer, run by Nantes University Hospital at 1 site in France.
Trial summary
The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Heel-free bandage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2019to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients over 18 years old
- Patient with at least one venous ulcer progressing for at least 4 weeks
- Patient coming for a specialized outpatient consultation called "vascular wound" at Nantes University Hospital
- Informed consent to participate in the study
- Social security insurance affiliation
Who cannot join
- Patients under guardianship
- Patient with major cognitive disorders incompatible with follow-up of protocol
- Pregnancy
- Patient with an open leg ulcer with a Systolic Pressure Index < 0.8
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers: Non-inferiority, Controlled, Randomized Trial
The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. The investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .
- Conditions
- Venous Ulcer
- Being tested
- Heel-free bandage
- Keywords
- varicose ulcer, compression bandages, patient compliance, heel, methods
- Medical subject headings
- Varicose Ulcer, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heel-free bandageOther
The bandage is made by leaving the heel uncovered.
| Study group | Role | What they receive |
|---|---|---|
| Heel included | No intervention | The bandage is made by including the heel as recommended in routine. |
| Heel not included | Experimental | he bandage is made by leaving the heel uncovered. Receives: Other: Heel-free bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interface Pressure at V3
Compare the interface pressure measurements generated by a medical compression bandage between two groups of patients with open venous ulcer(s) :
- experimental group: uncovered heel
- control group: heel covered by the bandage.
Measured: At V3 (i.e. between 4 to 8 weeks): 48h after the final bandagin (which occurs at V2)
Secondary outcomes (5)
Ankle Circumference
Compare the evolution or appearance of an edema in the ankle. The circumference of the ankle is measured with a tape measure using a technique called the figure of 8.
Measured: Day 0 and the last day at V3 (between week 4 and week 8)
Interface Pressure at V2
Compare, between the two groups, the interface pressures measured during the installation of bandage at home by the home nurse (V2 follow-up visit), compared to the recommended pressures (30-40 mmHg)
Measured: 48 hours before the last visit of the protocol V3 (V3 which occurs between 4 to 8 weeks)
Interface Pressure Between V2 and V3
Compare, between the two groups, the evolution of interface pressures after 48 hours of bandage wear.
Measured: At V2 and at V3, 48 hours apart (V3 which occurs between 4 to 8 weeks)
Patient Satisfaction: Questionnaire
Between the two groups, compare patient satisfaction with a heterogeneous questionnaire.
There is no scale or score. It is asked which type of bandage the patient prefers: with or without heel included?
Measured: At the last visit of the protocol (Between 4 and 8 weeks)
Number of Bandage Repairs
Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start11 Oct 2019
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne POTTIER, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046120
- Sponsor's protocol ID
- RC19_0072
- Acronym
- COMPARACHILLE
- Status last verified
- Feb 2026
- First submitted
- 2 Aug 2019
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mauvilain A, Durant C, Voisine A, Perrot B, Cartron E. Heel-Free Compression Bandaging for Venous Leg Ulcers: A Non-Inferiority Trial of Interface Pressure. Int Wound J. 2026 Oct;23(10):e71052. doi: 10.1111/iwj.71052.
PubMed 42851136
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers: Non-inferiority, Controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT04046120
- Acronym / sponsor ID
- COMPARACHILLE / RC19_0072
- Conditions
- Venous Ulcer
- Keywords
- varicose ulcer, compression bandages, patient compliance, heel, methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Posted 19 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. The investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heel included | No intervention | –The bandage is made by including the heel as recommended in routine. |
| Heel not included | Experimental | Other: Heel-free bandagehe bandage is made by leaving the heel uncovered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 years old
- Patient with at least one venous ulcer progressing for at least 4 weeks
- Patient coming for a specialized outpatient consultation called "vascular wound" at Nantes University Hospital
- Informed consent to participate in the study
- Social security insurance affiliation
Key exclusion criteria (4 listed)
- Patients under guardianship
- Patient with major cognitive disorders incompatible with follow-up of protocol
- Pregnancy
- Patient with an open leg ulcer with a Systolic Pressure Index < 0.8
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 |
|---|---|---|
| Heel-free bandageThe bandage is made by leaving the heel uncovered. | Other | Heel not included |
Primary outcome
Interface Pressure at V3
Time frame: At V3 (i.e. between 4 to 8 weeks): 48h after the final bandagin (which occurs at V2)
Compare the interface pressure measurements generated by a medical compression bandage between two groups of patients with open venous ulcer(s) : * experimental group: uncovered heel * control group: heel covered by the bandage.
5 secondary outcomes
Ankle Circumference
Time frame: Day 0 and the last day at V3 (between week 4 and week 8)
Interface Pressure at V2
Time frame: 48 hours before the last visit of the protocol V3 (V3 which occurs between 4 to 8 weeks)
Interface Pressure Between V2 and V3
Time frame: At V2 and at V3, 48 hours apart (V3 which occurs between 4 to 8 weeks)
Patient Satisfaction: Questionnaire
Time frame: At the last visit of the protocol (Between 4 and 8 weeks)
Number of Bandage Repairs
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42851136Mauvilain A, Durant C, Voisine A, Perrot B, Cartron E. Heel-Free Compression Bandaging for Venous Leg Ulcers: A Non-Inferiority Trial of Interface Pressure. Int Wound J. 2026 Oct;23(10):e71052. doi: 10.1111/iwj.71052.
- Individual participant dataSharing planned: No
Related trials for Venous Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
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.
Anne POTTIER principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heel-free bandage in people with Venous Ulcer, run by Nantes University Hospital 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 5 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: finished, as of the sponsor's last update on 19 Mar 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?
Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Interface Pressure at V3 (time frame: At V3 (i.e. between 4 to 8 weeks): 48h after the final bandagin (which occurs at V2)). 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 NCT04046120, 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 19 Mar 2026.