Autologous Adipose Tissue in the Treatment of Systemic Sclerosis Digital Ulcers (ADUL-SSc)
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|ClinicalTrials.gov Identifier: NCT03406988|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 25, 2018
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 with systemic sclerosis.
Systemic Sclerosis patients with digital ulcers will be randomized to be blindly treated with adipose tissue implantation or a sham procedure. Adipose tissue grafting will consist of injection at the base of the finger with digital ulcer of 0.5-1 ml of adipose tissue after centrifugation of fat aspirate. Sharm procedure will consist of false liposuction and local injection of saline solution.
The primary end-point will be to compare the cumulative prevalence of healed digital ulcers in the two groups within the following 8 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis Digital Ulcer||Procedure: Autologous fat grafting Procedure: Sham procedure||Not Applicable|
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 consequent fibrotic changes in the involved organs and tissues.
The most advanced stages of capillary loss may induce the formation of digital ulcers (DUs) on the fingertips.The healing of DUs is often a lengthy process requiring accurate and intensive topical and systemic treatment. Nevertheless, in a significant number of cases this therapeutic approach is ineffective and distal necrosis with subsequent tissue loss or phalangeal amputation may eventually occur.
In a recent open pilot study performed by Del Papa et al., it has been demonstrated that autologous adipose tissue grafting (AT-G), which is known to contain both adipose-derived stem cells and a stromal/vascular fraction, was effective in inducing prompt healing of long lasting DUs localized in the fingertips of a small number of patients with SSc. The DU healing was accompanied by the rapid disappearance of local ischemic pain and evidence of a partial restoration of the capillary bed in the digits when assessed by nailfold videocapillaroscopy (NVC).
With the purpose of confirming these preliminary results, the investigators have designed a monocentric randomized controlled study. In accordance with the study protocol, patients with a typical SSc-related DU on the fingertip will be randomized to undergo a regional AT-G with autologous fat as active therapy or a 'sham' procedure (SP) - that simulates the active treatment - as placebo treatment. All of the patients with SSc enrolled in both arms will be blind regarding the treatment received. Furthermore, during the study period all of the enrolled patients will receive the same systemic vasoactive and topical therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Candidate SSc patients will have only one active DU of at least 6 mm in diameter, lasting for at least 6 weeks, despite conventional vascular therapy. Patients with severe visceral manifestations, diabetes and treated with immune-suppressors and endothelin inhibitors will be excluded. Active therapy: implantation of 0.5-1 ml of autologous AT at the base of the finger with DU. Autologous AT will be obtained by liposuction from abdominal fat.
SP will be blindly performed in the control group to simulate the AT-G. A false liposuction will be performed followed by the injection of 0.5-1 ml of 0.9% saline solution at the base of the affected finger. Basal therapy: weekly iloprost infusion (0.5-2 ng/Kg/min), and calcium-channel blockers (oral nifedipine 20 mg daily) will be continued during the entire observation time in all of the patients recruited in both arms of the study. The administration of analgesics to alleviate the DU-related pain will be also allowed for each patient.
|Masking:||Double (Participant, Outcomes Assessor)|
Each enrolled patient will be blind regarding the administered therapy (active and sham procedure).
Evaluation of primary and secondary outcomes will be performed by assessors blind regarding the administered therapy.
|Official Title:||Regional Grafting of Autologous Adipose Tissue in the Treatment of Systemic Sclerosis Digital Ulcers: a Prospective Randomized Controlled Study|
|Actual Study Start Date :||July 18, 2017|
|Estimated Primary Completion Date :||March 31, 2018|
|Estimated Study Completion Date :||March 31, 2018|
Experimental: Autologous fat grafting
Implantation of 0.5-1 ml of autologous AT at the base of the finger with DU.
Procedure: Autologous fat grafting
Implantation of small amount of autologous adipose tissue at the base of the finger to induce a rapid healing of the distally located DU
Other Name: Iloprost infusion, oral nifedipine
Placebo Comparator: Sham procedure
False liposuction followed by the injection of 0.5-1 ml of 0.9% saline solution at the base of the affected finger.
Procedure: Sham procedure
Local injection of 0.5ml saline solution after a simulated liposuction procedure.
Other Name: Iloprost infusion, oral nifedipine
- Digital Ulcer healing [ Time Frame: 8 weeks after either autologus fat grafting or sham procedure. ]Prevalence of DU healing in the arm treated with autologous fat grafting in comparison with the prevalence of healing in the placebo group.
- Pain evaluation by Visual Analogue Scale (VAS) [ Time Frame: This evaluation will be done at baseline and at the 2nd, 4th, 6th, 8th week after interventions (either autologus fat grafting or sham procedure). ]
The pain VAS is a continuous scale comprised of a horizontal line of 10 centimeters (100 mm) in length, ranging from 0 (minimum= no pain) to 100 (worst imaginable pain). The respondents will be asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
In this study VAS score will be used to measure the decrease (or resolution) of pain with respect to baseline value in patients who will undergo treatment with autologous fat grafting (active arm) in comparison with patients of the placebo group.
- Neovascularization evaluation [ Time Frame: Baseline and 8 weeks after either autologus fat grafting or sham procedure. ]Increase of the number of capillaries assessed by NVC in the affected digit of patients treated with autologous fat grafting in comparison with patients of the placebo group.
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): NCT03406988
|Contact: Nicoletta Del Papa, MDfirstname.lastname@example.org|
|Contact: Claudio Vitali, MDemail@example.com|
|UOC Day Hospital Reumatologia, ASST G. Pini-CTO||Recruiting|
|Milan, Italy, 20122|
|Contact: Nicoletta Del Papa, MD +39-0258296415 firstname.lastname@example.org|
|Principal Investigator:||Nicoletta Del Papa, MD||ASST Gaetano Pini-CTO|