UlcerDrepanO2NCT04983654
Functional and Mechanistic Characterization of Limb Ulcers in Patients With Sickle Cell Disease
A study testing patients with limb ulcers and For patients without limb ulcers in people with Ulcer and Anemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Sickle Cell Disease is the most frequent genetic disease in the world (representing one birth over 1900, in France). The polymerization of the abnormal hemoglobin (i.e., HbS) when deoxygenated is at the origin of a mechanical distortion of red blood cells (RBC) into a crescent-like shape. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Ulcer, Anemia, Sickle Cell Disease
- What is being tested?
- patients with limb ulcers and For patients without limb ulcers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2022to 3 Oct 2023
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sickle Cell Disease (homozygous SS or Sb0)
- Age ≥ 18 years old
- Consent patients
- Social regimen
Who cannot join
- tutela or curatella
- Vaso occlusive crisis < 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Sickle Cell Disease is the most frequent genetic disease in the world (representing one birth over 1900, in France). The polymerization of the abnormal hemoglobin (i.e., HbS) when deoxygenated is at the origin of a mechanical distortion of red blood cells (RBC) into a crescent-like shape. Sickled RBCs are very fragile and rigid, which lead patients to have severe anemia and to develop frequent and repeated painful vaso-occlusive crises. Furthermore, the repetition of sickling-unsickling cycles causes irreversible damages to the RBCs, which shorten their half-life. Accumulation of free hemoglobin and heme in the plasma is involved in blood vessels lesions in both the macro- and micro- circulation.
The resulting vascular dysfunction could explain why limb ulcers are 10 fold more frequent in patients with sickle cell disease compared to the general population and may happen at a younger age. Limb ulcers induce significant morbidity (delay of healing between 9 and 26 weeks in the french cohort), and are associated to significant pain (needing opioid pain-killer) and increase the risk of infection. Cost of care is also increased. Moreover, ulcers induce missed school and work days.
Read more
Data on cutaneous microcirculation and ulcers physiopathology in patients with sickle cell disease are scarce. We want to realise a microcirculatory and neurological functional study of patients with with and without ulcers and a characterization of biomarkers present in the blood or in the wound fluid which can participate to ulcers physiopathology.
To ensure healing, adapted therapeutics are essential. Several strategies are proposed such as: lifestyle measures (venous compression, lower limb elevation, rest), dressings, hyperbaric oxygenotherapy (also used in diabetic ulcers). The project is devoted to study the mechanisms involved in leg ulcers and the effects of therapeutical/behavioral strategies.
- Conditions
- Ulcer, Anemia, Sickle Cell Disease
- Being tested
- patients with limb ulcers, For patients without limb ulcers
- Keywords
- limb ulcers, sickle cell disease, microcirculation, cytokine, wound fluid
- Medical subject headings
- Ulcer, Anemia, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with limb ulcersDiagnostic test
For patients with limb ulcers : at inclusion visit and after healing or at 6 months if ulcer does not heal:
- Microvascular analysis (laser doppler, TcPO2),
- Neurological analysis ( sensitivity testing with thermal and mechanical test),
- Analysis of physical characteristics of red blood cells and inflammatory marks,
- Analysis of cytokine and metalloproteases in the wound fluid,
- Assessment of healing according usual treatment
For patients without limb ulcersDiagnostic test
For patients without limb ulcers : at inclusion visit only
- Microvascular analysis (laser doppler, TcPO2),
- Neurological analysis (sensitivity testing with thermal and mechanical test),
- Analysis of physical characteristics of red blood cells and inflammatory marks
| Study group | Role | What they receive |
|---|---|---|
| Patients with limb ulcer | Experimental | Patients with sickle cell disease and suffering from limb ulcer Receives: Diagnostic Test: patients with limb ulcers |
| Patients without limb ulcer | Experimental | Patients with sickle cell disease without any limb ulcer Receives: Diagnostic Test: For patients without limb ulcers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alteration of cutaneous microvascular function and peripheral sensorial neurological function in patients with limb ulcers
Cutaneous microvascular function is assessed with :
- laser Doppler Including measurement of blood pressure before and after testing, heart rate before and after testing, cutaneous temperature, values of laser Doppler before and after vasodilatation with acetylcholine, deionized water, local heating (42°C)
- TcPO2 on the first intermetatarsal space and bordering ulcer Peripheral sensorial neurological function is assessed with Von Frey monofilament, hot (50°C)/cold (4°C) test, pic-touch test and pallesthesia.
Measured: Day 1
Secondary outcomes (5)
Modification of hemorheological red blood cells characteristics between patients with and without ulcers
Analysis of hemorheological characteristics in the 2 arms after blood test with blood viscosity and RBC rheological measurements (deformability/aggregation)
Measured: Day 1
Analysis of the composition of the wound fluid
Analysis of metalloproteases (MMP-8 and MMP-9) and inflammatory markers (TNF-alpha, Il-6, Il1-beta, VCAM 1, P-selectin) in the wound fluid
Measured: Day 1
Compare pro inflammatory markers in the blood between patients with and without ulcers
Analysis of inflammatory markers in the blood and comparison between the 2 arms
Measured: At initial visit
Assessment of healing
Delay of granulation tissue appearance, delay of healing according treatment used
Measured: through study completion, an average of 6 months
Compare microcirculation, pro inflammatory marker in the wound fluid and in the blood and hemorheological characteristics after usual treatment to obtain healing
Compare results (previously described) in the group of patients with ulcers, between initial and second visit
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start9 Feb 2022
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
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 UlcerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith CATELLA, Dr, Principal investigator, Service de Médecine Interne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983654
- Sponsor's protocol ID
- 69HCL21_0305
- Other IDs
- 2021-A01605-36
- Acronym
- DrepanO2
- Status last verified
- Dec 2025
- First submitted
- 13 Jul 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Catella J, Turpin E, Connes P, Nader E, Carin R, Martin M, Rezigue H, Nougier C, Dargaud Y, Josset-Lamaugarny A, Dugrain J, Marano M, Leuci A, Boisson C, Renoux C, Joly P, Poutrel S, Hot A, Guillot N, Fromy B. Impaired microvascular function in patients with sickle cell anemia and leg ulcers improved with healing. Br J Haematol. 2024 Dec;205(6):2459-2469. doi: 10.1111/bjh.19785. Epub 2024 Sep 24.
PubMed 39318045
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Mechanistic Characterization of Limb Ulcers in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04983654
- Acronym / sponsor ID
- DrepanO2 / 69HCL21_0305
- Conditions
- Ulcer, Anemia, Sickle Cell Disease
- Keywords
- limb ulcers, sickle cell disease, microcirculation, cytokine, wound fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 30 Jul 2021 (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.
Sickle Cell Disease is the most frequent genetic disease in the world (representing one birth over 1900, in France). The polymerization of the abnormal hemoglobin (i.e., HbS) when deoxygenated is at the origin of a mechanical distortion of red blood cells (RBC) into a crescent-like shape. Sickled RBCs are very fragile and rigid, which lead patients to have severe anemia and to develop frequent and repeated painful vaso-occlusive crises. Furthermore, the repetition of sickling-unsickling cycles causes irreversible damages to the RBCs, which shorten their half-life. Accumulation of free hemoglobin and heme in the plasma is involved in blood vessels lesions in both the macro- and micro- circulation.
The resulting vascular dysfunction could explain why limb ulcers are 10 fold more frequent in patients with sickle cell disease compared to the general population and may happen at a younger age. Limb ulcers induce significant morbidity (delay of healing between 9 and 26 weeks in the french cohort), and are associated to significant pain (needing opioid pain-killer) and increase the risk of infection. Cost of care is also increased. Moreover, ulcers induce missed school and work days.
Data on cutaneous microcirculation and ulcers physiopathology in patients with sickle cell disease are scarce. We want to realise a microcirculatory and neurological functional study of patients with with and without ulcers and a characterization of biomarkers present in the blood or in the wound fluid which can participate to ulcers physiopathology.
To ensure healing, adapted therapeutics are essential. Several strategies are proposed such as: lifestyle measures (venous compression, lower limb elevation, rest), dressings, hyperbaric oxygenotherapy (also used in diabetic ulcers). The project is devoted to study the mechanisms involved in leg ulcers and the effects of therapeutical/behavioral strategies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with limb ulcer | Experimental | Diagnostic Test: patients with limb ulcersPatients with sickle cell disease and suffering from limb ulcer |
| Patients without limb ulcer | Experimental | Diagnostic Test: For patients without limb ulcersPatients with sickle cell disease without any limb ulcer |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sickle Cell Disease (homozygous SS or Sb0)
- Age ≥ 18 years old
- Consent patients
- Social regimen
Key exclusion criteria (2 listed)
- tutela or curatella
- Vaso occlusive crisis < 1 month
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 |
|---|---|---|
| patients with limb ulcersFor patients with limb ulcers : at inclusion visit and after healing or at 6 months if ulcer does not heal: * Microvascular analysis (laser doppler, TcPO2), * Neurological analysis ( sensitivity testing with thermal and mechanical test), * Analysis of physical characteristics of red blood cells and inflammatory marks, * Analysis of cytokine and metalloproteases in the wound fluid, * Assessment of healing according usual treatment | Diagnostic test | Patients with limb ulcer |
| For patients without limb ulcersFor patients without limb ulcers : at inclusion visit only * Microvascular analysis (laser doppler, TcPO2), * Neurological analysis (sensitivity testing with thermal and mechanical test), * Analysis of physical characteristics of red blood cells and inflammatory marks | Diagnostic test | Patients without limb ulcer |
Primary outcome
Alteration of cutaneous microvascular function and peripheral sensorial neurological function in patients with limb ulcers
Time frame: Day 1
Cutaneous microvascular function is assessed with : * laser Doppler Including measurement of blood pressure before and after testing, heart rate before and after testing, cutaneous temperature, values of laser Doppler before and after vasodilatation with acetylcholine, deionized water, local heating (42°C) * TcPO2 on the first intermetatarsal space and bordering ulcer Peripheral sensorial neurological function is assessed with Von Frey monofilament, hot (50°C)/cold (4°C) test, pic-touch test and pallesthesia.
5 secondary outcomes
Modification of hemorheological red blood cells characteristics between patients with and without ulcers
Time frame: Day 1
Analysis of the composition of the wound fluid
Time frame: Day 1
Compare pro inflammatory markers in the blood between patients with and without ulcers
Time frame: At initial visit
Assessment of healing
Time frame: through study completion, an average of 6 months
Compare microcirculation, pro inflammatory marker in the wound fluid and in the blood and hemorheological characteristics after usual treatment to obtain healing
Time frame: through study completion, an average of 6 months
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 19 Dec 2025.
- Results publication: PubMed 39318045Catella J, Turpin E, Connes P, Nader E, Carin R, Martin M, Rezigue H, Nougier C, Dargaud Y, Josset-Lamaugarny A, Dugrain J, Marano M, Leuci A, Boisson C, Renoux C, Joly P, Poutrel S, Hot A, Guillot N, Fromy B. Impaired microvascular function in patients with sickle cell anemia and leg ulcers improved with healing. Br J Haematol. 2024 Dec;205(6):2459-2469. doi: 10.1111/bjh.19785. Epub 2024 Sep 24.
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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.
Judith CATELLA, Dr principal investigator
Service de Médecine Interne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients with limb ulcers and For patients without limb ulcers in people with Ulcer and Anemia, run by Hospices Civils de Lyon 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 4 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 19 Dec 2025. 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?
Alteration of cutaneous microvascular function and peripheral sensorial neurological function in patients with limb ulcers (time frame: Day 1). 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 NCT04983654, 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 Dec 2025.