Functional and Mechanistic Characterization of Limb Ulcers in Patients With Sickle Cell Disease (DrepanO2)

December 13, 2025 updated by: Hospices Civils de Lyon

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • Groupement Hospitalier Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sickle Cell Disease (homozygous SS or Sb0)
  • Age ≥ 18 years old
  • Consent patients
  • Social regimen

Exclusion Criteria:

  • tutela or curatella
  • Vaso occlusive crisis < 1 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with limb ulcer
Patients with sickle cell disease and suffering from limb ulcer
Diagnostic test: patients with limb ulcers

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
Experimental: Patients without limb ulcer
Patients with sickle cell disease without any limb ulcer
Diagnostic test: For patients without limb ulcers

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modification of hemorheological red blood cells characteristics between patients with and without ulcers
Time Frame: Day 1
Analysis of hemorheological characteristics in the 2 arms after blood test with blood viscosity and RBC rheological measurements (deformability/aggregation)
Day 1
Analysis of the composition of the wound fluid
Time Frame: Day 1
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
Day 1
Compare pro inflammatory markers in the blood between patients with and without ulcers
Time Frame: At initial visit
Analysis of inflammatory markers in the blood and comparison between the 2 arms
At initial visit
Assessment of healing
Time Frame: through study completion, an average of 6 months
Delay of granulation tissue appearance, delay of healing according treatment used
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
Compare results (previously described) in the group of patients with ulcers, between initial and second visit
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Judith CATELLA, Dr, Service de Médecine Interne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2022

Primary Completion (Actual)

October 3, 2023

Study Completion (Actual)

October 3, 2023

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_0305
  • 2021-A01605-36 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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