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NCT04983654: DrepanO2
Functional and Mechanistic Characterization of Limb Ulcers in Patients With Sickle Cell Disease
NA trial testing patients with limb ulcers in Ulcer in 70 participants. Completed in 3 October 2023.
3 October 2023
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 70 |
| Start date | 9 February 2022 |
| Primary completion | 3 October 2023 |
| Estimated completion | 3 October 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- patients with limb ulcers
- For patients without limb ulcers
Conditions studied
- Ulcer — all drugs for Ulcer →
- Anemia — all drugs for Anemia →
- Sickle Cell Disease — all drugs for Sickle Cell Disease →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
Adults 18 to 130, any sex, with Ulcer or Anemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Impaired microvascular function in patients with sickle cell anemia and leg ulcers improved with healing.
Catella J, Turpin E, Connes P, Nader E, et al · · 2024 · cited 1× · PMID 39318045 · DOI 10.1111/bjh.19785
Verify or expand the search:
- PubMed search for NCT04983654
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04983654 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 19 December 2025
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