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Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

NCT02987101 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-12-08

No results posted yet for this study

Summary

Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction as an adjunct to standard wound care.

Conditions

  • Leg Ulcer

Interventions

PROCEDURE

Liposuction

Adipose tissue is harvested by liposuction from either abdomen or thighs.

OTHER

Standard wound care

Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.

DRUG

Adipose-Derived Regenerative Cells

Cells isolated from adipose-derived tissue will be injected locally around and under the wound.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Jens A Sørensen, MD PhD · Dept. Plastic Surgery, OUH, Consultant, Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Denmark

Study Locations

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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 NCT02987101 on ClinicalTrials.gov