NCT04483934

Brief Summary

Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2014

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

October 28, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

July 17, 2020

Last Update Submit

July 21, 2020

Conditions

Trophic UlcerNon-healing WoundNon-Healing Ulcer of Skin

Keywords

Trophic UlcerNon-healing WoundDermal fibroblasts

Outcome Measures

Primary Outcomes (2)

  • Number of patients with tropic ulcers cured

    Number of patients cured

    1 month

  • Number of patients with treatment-related adverse events

    Fibroblasts injection related adverse events assessed by blood count and function tests

    4 weeks

Study Arms (1)

Patients treated with dermal fibroblasts

EXPERIMENTAL

Cultured dermal fibroblasts and LED phototherepy

Biological: Dermal fibroblastsDevice: LED phototherapy

Interventions

Dermal fibroblastsBIOLOGICAL

Cultured autologous dermal fibroblasts. For PR: The name "dermal fibroblasts" is exactly the name of the cell product registered by our ministry of health. There is no trade or international name.

Patients treated with dermal fibroblasts
LED phototherapyDEVICE

LED phototherapy

Patients treated with dermal fibroblasts

Eligibility Criteria

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

You may qualify if:

  • Trophic Ulcers
  • Chronic non-healing wounds

You may not qualify if:

  • acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
  • mental disorders
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, 220072, Belarus

Location

Study Officials

  • Igor Volotovski, Prof

    Head of the Lab of Institute of Biophysics and Cell Engineering

    STUDY DIRECTOR

  • Stanislav Tretyak, Prof

    Head of 2nd Department of Surgical Diseases of BSMU

    STUDY DIRECTOR

  • Evgeny Baranov, Dr

    Ass prof of 2nd Department of Surgical Diseases of BSMU

    PRINCIPAL INVESTIGATOR

  • Zinaida Kvacheva, Dr

    Lead Researcher of Institute of Biophysics and Cell Engineering

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 23, 2020

Study Start

October 28, 2014

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)