Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Leg Ulcer Clinical Trial

Official title:

Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02987101
• Other study ID #: S-201502002
• Status: Recruiting
• Phase: N/A
• First received: November 24, 2016
• Last updated: December 6, 2016
• Start date: November 2016
• Est. completion date: June 2018

Study information

• Verified date: December 2016
• Source: Odense University Hospital
• Contact: Navid M Toyserkani, MD
• Phone: +4550383833
• Email: navid.m.toyserkani[@]rsyd.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Distal blood pressure measurement	Change in distal blood pressure measurement before and 6 months after treatment	6 months	No
Secondary	Transcutaneous oxygen tension	Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.	6 months	No
Secondary	Treatment-related adverse events	Monitoring of any side effects or complications related to intervention	6 months	No