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Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

NCT ID: NCT02987101

Last Updated: 2016-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Liposuction

Intervention Type PROCEDURE

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

Standard wound care

Intervention Type OTHER

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

Adipose-Derived Regenerative Cells

Intervention Type DRUG

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

Standard of care

Standard wound care is given independent of this study.

Group Type OTHER

Standard wound care

Intervention Type OTHER

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

Interventions

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Liposuction

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

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Adipose-Derived Regenerative Cells

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Navid Toyserkani

Resident, PhD fellow, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens A Sørensen, MD PhD

Role: STUDY_CHAIR

Dept. Plastic Surgery, OUH, Consultant, Professor

Locations

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Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Navid M Toyserkani, MD

Role: CONTACT

Phone: +4550383833

Email: [email protected]

Facility Contacts

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Navid M Toyserkani, MD

Role: primary

Other Identifiers

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S-201502002

Identifier Type: -

Identifier Source: org_study_id