Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

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.

Study Overview

• Status: Unknown
• Conditions: Leg Ulcer
• Intervention / Treatment: Procedure: Liposuction; Other: Standard wound care; Drug: Adipose-Derived Regenerative Cells

Detailed Description

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 (SVF) as an adjunct to standard wound care.

The plan is to include 30 patients with arterial or arteriovenous chronic leg ulcers and these are randomized in two groups of which one receives standard wound care only and the other group receives autologous stromal vascular fraction treatment in addition to standard wound care.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Navid M Toyserkani, MD; Phone Number: +4550383833; Email: navid.m.toyserkani@rsyd.dk
    • Principal Investigator: Navid M Toyserkani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Arteriovenous chronic leg ulcer
• Present beyond 4 months
• Conservative treatment not leading to progress
• Wound size between 2-30cm2
• ankle-brachial index (ABI) ( 50-90% and/or toe pressure 50-70% and where ankle pressure > 60 mmHg or toe pressure > 40 mmHg
• Written informed consent

Exclusion Criteria:

• Uncontrolled wound infection
• Osteomyelitis
• Hemoglobin <6.0mmol/L
• HbA1c >80mmol/mol
• Underlying malignancy
• Pregnancy or lactating
• Renal insufficiency requiring dialysis
• Charcot foot
• Underlying malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Autologous SVF + Standard of care; local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study.	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.
OTHER: Standard of care; Standard wound care is given independent of this study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound size	Photography is taken every 2 weeks until complete wound healing. Final follow-up date regardless of complete wound healing or not is 6 months.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distal blood pressure measurement	Change in distal blood pressure measurement before and 6 months after treatment	6 months
Transcutaneous oxygen tension	Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.	6 months
Treatment-related adverse events	Monitoring of any side effects or complications related to intervention	6 months

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Study Chair: Jens A Sørensen, MD PhD, Dept. Plastic Surgery, OUH, Consultant, Professor

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2018
• Study Completion (ANTICIPATED): June 1, 2018

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (ESTIMATE): December 8, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Leg Ulcer
• Other Study ID Numbers: S-201502002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED