Mesenchymal Stromal Cell Derivatives in the Treatment of Chronic Diabetic Foot Ulcers Type 1 and 2
MSCDTDFU
1 other identifier
interventional
51
0 countries
N/A
Brief Summary
The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2) in adults. A third of the participants will receive dac-MSCs and Triticum vulgare (Fitostimoline) in combination, the other third MSCs and Fitostimoline in combination, and the last third only Fitosimoline. This study will be a randomized, blind, and parallel and controlled-group trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2017
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedOctober 24, 2016
October 1, 2016
1.4 years
October 19, 2016
October 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound size change
Wound size will be assessed using a SilhouetteMobile camera (digital planimetry)
One year
Secondary Outcomes (3)
Granulation tissue percentage
One year
Pigmentation change
One year
Presence of Exudate
One year
Study Arms (3)
dac-MSCs and Fitostimoline
EXPERIMENTALIntradermic application of dac-MSCs (1 mL ) in four equidistant points around the ulcer (twice: day 0 and 7) and topical application of fitostimoline every other day
MSCs and Fitostimoline
ACTIVE COMPARATORIntradermic application of MSCs (500,000 cells/mL) in four equidistant points around the ulcer (once: day 0 ) and topical application of fitostimoline every other day
Fitostimoline
ACTIVE COMPARATORTopical application of fitostimoline every other day
Interventions
Triticum vulgare
Eligibility Criteria
You may qualify if:
- Males and females between the ages of 40 and 80 years, inclusive, with Type 1 or 2 diabetes as defined by the American Diabetes Association
- Stable glycemic control
- Transcutaneous oxygen measurement \> 30 mmHg
- Ulcer present at least for 1 month
- Wound size between 0.5 and 5 cm2
- Subjects that require endovascular surgical intervention
- Subjects must have adequate nutrition (albumin level \> 2 g/dL and prealbumin level \> 15 mg/dL)
You may not qualify if:
- Previous or current diagnoses with one of the following: cancer, symptomatic coronary artery disease, brain disease, kidney failure, blood disorders
- Taking immunosuppressive and cytotoxic drugs
- Presence of active systemic infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia L Sossa-Melo, MD
Universidad Autónoma de Bucaramanga
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 19, 2016
First Posted
October 24, 2016
Study Start
January 1, 2017
Primary Completion
June 1, 2018
Study Completion
January 1, 2019
Last Updated
October 24, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share