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

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ClinicalTrials.gov Identifier: NCT04983654
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Ulcer Anemia Sickle Cell Disease Diagnostic Test: patients with limb ulcers Diagnostic Test: For patients without limb ulcers Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Functional and Mechanistic Characterization of Limb Ulcers in Patients With Sickle Cell Disease
Actual Study Start Date : February 9, 2022
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. Assessment of healing [ Time Frame: through study completion, an average of 6 months ]
    Delay of granulation tissue appearance, delay of healing according treatment used

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04983654


Contacts
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Contact: Judith CATELLA, Dr 04 72 11 77 91 ext +33 judith.catella@chu-lyon.fr

Locations
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France
Groupement Hospitalier Edouard Herriot Recruiting
Lyon, France, 69437
Contact: Judith CATELLA, Dr    04 72 11 77 91    judith.catella@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Judith CATELLA, Dr Service de Médecine Interne
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04983654    
Other Study ID Numbers: 69HCL21_0305
2021-A01605-36 ( Other Identifier: ID-RCB )
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
limb ulcers
sickle cell disease
microcirculation
cytokine
wound fluid
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Ulcer
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn