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Autologous Adipose Tissue in the Treatment of Systemic Sclerosis Digital Ulcers

NCT03406988 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-01-25

No results posted yet for this study

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 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.

Conditions

Interventions

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

PROCEDURE

Sham procedure

Local injection of 0.5ml saline solution after a simulated liposuction procedure.

Sponsors & Collaborators

  • Società Italiana di Reumatologia

    collaborator UNKNOWN

  • ASST Gaetano Pini-CTO

    lead OTHER

Principal Investigators

  • Nicoletta Del Papa, MD · ASST Gaetano Pini-CTO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-18
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03406988 on ClinicalTrials.gov