NCT04896437

Brief Summary

There are a limited number of reports related to the direct use of non-centrifuged adipose tissue graft in the literature. This preliminary study aims to present our experience on the efficacy of autologous fat graft use without centrifuging in the treatment of lower extremity wounds.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

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

March 2, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

3.2 years

First QC Date

May 6, 2021

Last Update Submit

May 17, 2021

Conditions

Wound Healing Delayed

Keywords

diabetic foodlower extremityfat graftnonentrifuged

Outcome Measures

Primary Outcomes (1)

  • Wounds examination

    Collection of the data from clinical observation and photograph records were made to follow the wounds. the observations were made during changing the wound dressing and generally every three days.

    6 months

Secondary Outcomes (2)

  • Wounds classification according to data from files and photographs

    3 months

  • Final evaluation and data achieving from files and exam carts

    3 months

Interventions

non-centrifuge fat graft application to the woundsPROCEDURE

Autologous fat grafts were harvested from abdominal or gluteal regions of the patients and injected into the wound bed and wound environment. Clinical observation and photograph records were used to follow the wounds.

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

16 lower extremity wounds were included in the study between January 2016-October 2019 years. All patients were treated by two surgeons in the same clinic. The wounds were those that continued for at least three months of high to moderate exudate and required open management of the secondary intervention. The etiologies of the wounds were diabetic, venous or traumatic ulcers.

You may qualify if:

  • diabetic,
  • venous
  • traumatic wounds

You may not qualify if:

  • Malignancy,
  • A life expectation \<1 year,
  • Chemical or radiation exposure.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Goncalves AI, Gershovich PM, Rodrigues MT, Reis RL, Gomes ME. Human adipose tissue-derived tenomodulin positive subpopulation of stem cells: A promising source of tendon progenitor cells. J Tissue Eng Regen Med. 2018 Mar;12(3):762-774. doi: 10.1002/term.2495. Epub 2017 Oct 4.

    PMID: 28593712BACKGROUND

  • Hivernaud V, Lefourn B, Robard M, Guicheux J, Weiss P. Autologous fat grafting: A comparative study of four current commercial protocols. J Plast Reconstr Aesthet Surg. 2017 Feb;70(2):248-256. doi: 10.1016/j.bjps.2016.11.022. Epub 2016 Dec 14.

    PMID: 28043786BACKGROUND

  • Conde-Green A, Marano AA, Lee ES, Reisler T, Price LA, Milner SM, Granick MS. Fat Grafting and Adipose-Derived Regenerative Cells in Burn Wound Healing and Scarring: A Systematic Review of the Literature. Plast Reconstr Surg. 2016 Jan;137(1):302-312. doi: 10.1097/PRS.0000000000001918.

    PMID: 26710034BACKGROUND

  • Tuncel U, Kostakoglu N, Turan A, Cevik B, Cayli S, Demir O, Elmas C. The Effect of Autologous Fat Graft with Different Surgical Repair Methods on Nerve Regeneration in a Rat Sciatic Nerve Defect Model. Plast Reconstr Surg. 2015 Dec;136(6):1181-1191. doi: 10.1097/PRS.0000000000001822.

    PMID: 26273733BACKGROUND

  • Moyer HR, Namnoum JD. Autologous Fat Transfer: The Progenitor Cell Response to Different Recipient Environments. Aesthet Surg J. 2014 Aug;34(6):932-40. doi: 10.1177/1090820X14536903. Epub 2014 Aug 1.

    PMID: 24936093BACKGROUND

  • Hyldig K, Riis S, Pennisi CP, Zachar V, Fink T. Implications of Extracellular Matrix Production by Adipose Tissue-Derived Stem Cells for Development of Wound Healing Therapies. Int J Mol Sci. 2017 May 31;18(6):1167. doi: 10.3390/ijms18061167.

    PMID: 28561757BACKGROUND

  • van de Vyver M. Intrinsic Mesenchymal Stem Cell Dysfunction in Diabetes Mellitus: Implications for Autologous Cell Therapy. Stem Cells Dev. 2017 Jul 15;26(14):1042-1053. doi: 10.1089/scd.2017.0025. Epub 2017 May 18.

    PMID: 28447876BACKGROUND

  • Hur W, Lee HY, Min HS, Wufuer M, Lee CW, Hur JA, Kim SH, Kim BK, Choi TH. Regeneration of full-thickness skin defects by differentiated adipose-derived stem cells into fibroblast-like cells by fibroblast-conditioned medium. Stem Cell Res Ther. 2017 Apr 20;8(1):92. doi: 10.1186/s13287-017-0520-7.

    PMID: 28427476BACKGROUND

Study Officials

  • Umut Tuncel, Assoc Prof

    Samsun Liv Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 21, 2021

Study Start

March 2, 2016

Primary Completion

May 13, 2019

Study Completion

March 18, 2020

Last Updated

May 21, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share