NCT02799290

Brief Summary

Adipose Tissue Extract (ATE) has been found to be an autologous source of growth factors with proven in vitro angiogenic and adipogenic properties.It is obtained by a simple lipoaspirate procedure. We sought to compare the effect of ATE with another known source, platelet-rich plasma to compare the wound healing characteristics on skin graft donor sites.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

June 9, 2016

Results QC Date

October 26, 2016

Last Update Submit

December 13, 2020

Conditions

Wound Healing Disturbance of

Outcome Measures

Primary Outcomes (1)

  • Wound Re-epithelization

    observational-digital photography with specialized custom-made software

    30 days

Secondary Outcomes (3)

  • Scar Properties

    30 and 60 days

  • Oxygenated Hemoglobin

    day 30 and 60

  • Melanin Concentration in Wound

    day 30 and 60

Study Arms (3)

CONTROL

NO INTERVENTION

No intervention

ADIPOSE TISSUE EXTRACT

EXPERIMENTAL

Adipose Tissue extract application

Biological: ADIPOSE TISSUE EXTRACT

PLATELET-RICH PLASMA GEL

EXPERIMENTAL

PLATELET RICH PLASMA GEL APPLICATION

Biological: PLATELET-RICH PLASMA GEL

Interventions

ADIPOSE TISSUE EXTRACTBIOLOGICAL

Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration

Also known as: ATE
ADIPOSE TISSUE EXTRACT
PLATELET-RICH PLASMA GELBIOLOGICAL

Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions

Also known as: PRP
PLATELET-RICH PLASMA GEL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • donor site indication

You may not qualify if:

  • immunosupressive states
  • terminal renal insufficiency
  • pregnancy
  • coagulation dyscrasias
  • active infection in donor site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jenny Lopez, Ilkka Kaartinen

Tampere, Pirkanmaa, 33521, Finland

Location

Related Publications (2)

  • Sarkanen JR, Kaila V, Mannerstrom B, Raty S, Kuokkanen H, Miettinen S, Ylikomi T. Human adipose tissue extract induces angiogenesis and adipogenesis in vitro. Tissue Eng Part A. 2012 Jan;18(1-2):17-25. doi: 10.1089/ten.TEA.2010.0712. Epub 2011 Oct 4.

    PMID: 21902602RESULT

  • Sarkanen JR, Ruusuvuori P, Kuokkanen H, Paavonen T, Ylikomi T. Bioactive acellular implant induces angiogenesis and adipogenesis and sustained soft tissue restoration in vivo. Tissue Eng Part A. 2012 Dec;18(23-24):2568-80. doi: 10.1089/ten.TEA.2011.0724. Epub 2012 Aug 17.

    PMID: 22738319RESULT

Results Point of Contact

Title
Ilkka Kaartinen
Organization
Tampere University Hospital
ilkka.kaartinen@pshp.fi
505687096

Study Officials

  • Timo Ylikomi, PhD

    Tampere University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 14, 2016

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 7, 2021

Results First Posted

January 7, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

If required, individual data can be shown

Locations

FI(1)