Status:
UNKNOWN
Autologous Adipose Tissue in the Treatment of Systemic Sclerosis Digital Ulcers
Lead Sponsor:
ASST Gaetano Pini-CTO
Collaborating Sponsors:
Società Italiana di Reumatologia
Conditions:
Systemic Sclerosis
Digital Ulcer
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A randomized controlled trial will be performed to confirm preliminary uncontrolled data indicating that regional adipose tissue grafting is effective in inducing digital ulcer healing in patients wit...
Detailed Description
Systemic sclerosis (SSc) is an autoimmune disease characterized by a multifactorial pathological process where a central role is played by the progressive loss of the microvascular bed, with the conse...
Eligibility Criteria
Inclusion
- Patients candidate for enrollment in the study have to meet the 2013 classification criteria of the American College of Rheumatology/European League Against Rheumatism for SSc;
- Patients may have either the limited cutaneous or the diffuse cutaneous variants of SSc;
- All of the candidate patients must have only one active DU (cardinal ulcer), lasting for at least 6 weeks prior to enrolment time and showing no tendency to heal despite intravenous iloprost (0.5-2 ng/Kg/min), the oral administration of calcium-channel blockers (nifedipine) and local medication with surgical removal of necrotic tissue.
Exclusion
- Presence of severe extra-cutaneous manifestations, such as cardiac, lung and renal involvement;
- Concomitant treatment with immune-suppressive therapies (including prednisone equivalent \>10 mg);
- Current therapy with dual and selective endothelin inhibitors;
- Concomitant diabetes and/or other vascular diseases;
- Current pregnancy or breastfeeding.
Key Trial Info
Start Date :
July 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03406988
Start Date
July 18 2017
End Date
March 31 2018
Last Update
January 25 2018
Active Locations (1)
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1
UOC Day Hospital Reumatologia, ASST G. Pini-CTO
Milan, Italy, 20122