Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Not Applicable

• Conditions: Leg Ulcer
• Interventions: Procedure: Liposuction; Other: Standard wound care; Drug: Adipose-Derived Regenerative Cells

• Registration Number: NCT02987101
• Lead Sponsor: Odense University Hospital

Brief 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.

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-24
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-06
• Last Update Submitted: 2016-12-06
• Study First Posted: 2016-12-08
• Last Update Posted: 2016-12-08
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous SVF + Standard of care	Liposuction	local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study.
Autologous SVF + Standard of care	Standard wound care	local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study.
Autologous SVF + Standard of care	Adipose-Derived Regenerative Cells	local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study.
Standard of care	Standard wound care	Standard wound care is given independent of this study.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark