Abstract
BackgroundA randomized controlled trial (RCT) was performed to confirm preliminary uncontrolled data indicating that regional adipose tissue (AT) grafting (G) is effective in inducing ischemic digital ulcer (IDU) healing in patients with systemic sclerosis (SSc).Patients and methodsSSc patients with IDUs were randomized to be blindly treated with AT-G or a sham procedure (SP). AT-G consisted of injection, at the base of the finger with the IDU, of 0.5–1 ml AT after centrifugation of fat aspirate. The SP consisted of false liposuction and local injection of saline solution. The primary endpoint was to compare the cumulative prevalence of healed IDUs in the two groups within the following 8 weeks.ResultsAT-G and the SP were carried out in 25 and 13 patients, respectively. The two groups were comparable for age, gender, disease duration, and SSc subtypes. IDU healing was observed in 23/25 and 1/13 patients treated with AT-G and the SP, respectively (p < 0.0001). The 12 patients who received the unsuccessful SP underwent a rescue AT-G. In all of them, IDU healing was observed after 8 weeks of observation. It was noticeable that in the AT-G-treated patients a significant reduction of pain intensity (measured by visual analogue scale) was recorded after 4 and 8 weeks (p < 0.0001 in all cases). Similarly, a significant increase of capillary numbers in the affected finger was recorded by nailfold videocapillaroscopy after 4 and 8 weeks (p < 0.0001 in both cases).ConclusionThis RCT strongly confirms that AT-G is effective in inducing IDU healing in SSc patients.Trial registrationClinicalTrials.gov, NCT03406988. Registered retrospectively on 25 January 2018.
Highlights
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 [1]
Calculation of the patients’ samples and randomization procedure Starting from the results of our open study that showed 100% of ischemic digital ulcer (IDU) healing within 10 weeks in the patients treated with adipose tissue (AT)-G, and from some literature data demonstrating that, in patients suffering from distal IDUs and treated with standard vasoactive therapy, ulcer healing was observed in around 15% after 9 weeks [18], we have considered it plausible to achieve IDU healing after 8 weeks of observation in at least 80% of patients treated with AT-G and in no more than 30% of the control patients receiving the sham procedure (SP)
The analysis demonstrated that the primary endpoint of the study was already reached
Summary
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 [1]. The progressive derangement of the microvascular architecture can be observed in finger periungueal areas by means of nailfold videocapillaroscopy (NVC). This simple and low-cost technique enables careful observation of the evolutionary steps of this pathological process. The most advanced stages of capillary loss may induce the formation of digital ulcers (DUs) on the fingertips This event, which has been observed in around half of the patients [2, 4, 5], commonly leads to a significant deterioration of the patient’s quality of life because of the often-severe disabling pain and the difficulty in performing the simplest daily living activities. A randomized controlled trial (RCT) was performed to confirm preliminary uncontrolled data indicating that regional adipose tissue (AT) grafting (G) is effective in inducing ischemic digital ulcer (IDU) healing in patients with systemic sclerosis (SSc)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
