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Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Primary Purpose

Leg Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Liposuction
Standard wound care
Adipose-Derived Regenerative Cells
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Autologous SVF + Standard of care

Standard of care

Arm Description

local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study.

Standard wound care is given independent of this study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2016
Last Updated
December 6, 2016
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02987101
Brief Title
Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
Official Title
Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous SVF + Standard of care
Arm Type
Experimental
Arm Description
local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study.
Arm Title
Standard of care
Arm Type
Other
Arm Description
Standard wound care is given independent of this study.
Intervention Type
Procedure
Intervention Name(s)
Liposuction
Intervention Description
Adipose tissue is harvested by liposuction from either abdomen or thighs.
Intervention Type
Other
Intervention Name(s)
Standard wound care
Intervention Description
Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.
Intervention Type
Drug
Intervention Name(s)
Adipose-Derived Regenerative Cells
Intervention Description
Cells isolated from adipose-derived tissue will be injected locally around and under the wound.
Primary Outcome Measure Information:
Title
Change in wound size
Description
Photography is taken every 2 weeks until complete wound healing. Final follow-up date regardless of complete wound healing or not is 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Distal blood pressure measurement
Description
Change in distal blood pressure measurement before and 6 months after treatment
Time Frame
6 months
Title
Transcutaneous oxygen tension
Description
Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.
Time Frame
6 months
Title
Treatment-related adverse events
Description
Monitoring of any side effects or complications related to intervention
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Navid M Toyserkani, MD
Phone
+4550383833
Email
navid.m.toyserkani@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens A Sørensen, MD PhD
Organizational Affiliation
Dept. Plastic Surgery, OUH, Consultant, Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Navid M Toyserkani, MD
Phone
+4550383833
Email
navid.m.toyserkani@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Navid M Toyserkani, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

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