Foot Ulcer, DiabeticPhase 1/2MSCDTDFUNCT02943486
Mesenchymal Stromal Cell Derivatives in the Treatment of Chronic Diabetic Foot Ulcers Type 1 and 2
A Phase 1/2 study testing dac-MSCs, MSCs and Fitostimoline in people with Foot Ulcer, Diabetic, run by Universidad Autónoma de Bucaramanga.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- dac-MSCs, MSCs and Fitostimoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mesenchymal Stromal Cell Derivatives: a New Alternative and Potential Product for the Treatment of Diabetic Foot Ulcers 1 and 2
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.
Read the detailed description
Conventional treatments such as dry, wet or active dressings are effective only in 50% of patients with diabetic foot ulcer. The remaining 50% of patients have non-responding recoveries that leads to amputation of the compromised limbs. Currently, the administration of mesenchymal stem cells (MSCs) in animal models or in small groups of patients with diabetic foot ulcer has shown to be safe and effective. Particularly, the use of these cells induce regeneration, both in the dermis and the epidermis. Nevertheless, MSC transplantation has some limitations, for instance, time restrictions in the availability of cells due to their isolation and expansion as well as the complex and costly large-scale production. In the same manner, the cryopreservation might cause deleterious effects that affect the biological activity of the cells and a medical professional should conduct the cell administration. In addition, different studies report variability in the results due to the inconsistency in the methods that they used (extraction protocols, cultivation, expansion and administration). The investigators' recent studies in mice with skin lesions, particularly type 1 diabetes, have shown that the presence of the cells is not necessary to promote skin regeneration and the administration of dac-MSCs is sufficient to stimulate would healing.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- dac-MSCs, MSCs, Fitostimoline
- Keywords
- Mesenchymal stromal cells, Fitostimoline, MSC derivatives, Diabetes
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dac-MSCsOther
Also called Cell-free therapy
Cell-free therapy
MSCsOther
Also called Cell-based therapy
Cell-based therapy
FitostimolineDrug
Also called Triticum vulgare
Triticum vulgare
| Study group | Role | What they receive |
|---|---|---|
| dac-MSCs and Fitostimoline | Experimental | Intradermic 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 Receives: Other: dac-MSCs; Drug: Fitostimoline |
| MSCs and Fitostimoline | Active comparator | Intradermic 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 Receives: Other: MSCs; Drug: Fitostimoline |
| Fitostimoline | Active comparator | Topical application of fitostimoline every other day Receives: Drug: Fitostimoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound size change
Wound size will be assessed using a SilhouetteMobile camera (digital planimetry)
Measured: One year
Secondary outcomes (3)
Granulation tissue percentage
Images will be used to assess the amount of granulation tissue present in the wound
Measured: One year
Pigmentation change
Digital images will be used to evaluate color changes in the wound
Measured: One year
Presence of Exudate
Visual observation of the wound to determine the presence of exudate
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Bucaramanga
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Responsible party
- Principal investigator, Claudia Lucia Sossa Melo, Universidad Autónoma de Bucaramanga
- Investigators
- Claudia L Sossa-Melo, MD, Principal investigator, Universidad Autónoma de Bucaramanga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943486
- Sponsor's protocol ID
- 124174455522
- Acronym
- MSCDTDFU
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stromal Cell Derivatives: a New Alternative and Potential Product for the Treatment of Diabetic Foot Ulcers 1 and 2
- ClinicalTrials.gov ID
- NCT02943486
- Acronym / sponsor ID
- MSCDTDFU / 124174455522
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- Mesenchymal stromal cells, Fitostimoline, MSC derivatives, Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Universidad Autónoma de BucaramangaUniversity, hospital or other
- Collaborators
- Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- Jan 2017
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Conventional treatments such as dry, wet or active dressings are effective only in 50% of patients with diabetic foot ulcer. The remaining 50% of patients have non-responding recoveries that leads to amputation of the compromised limbs. Currently, the administration of mesenchymal stem cells (MSCs) in animal models or in small groups of patients with diabetic foot ulcer has shown to be safe and effective. Particularly, the use of these cells induce regeneration, both in the dermis and the epidermis. Nevertheless, MSC transplantation has some limitations, for instance, time restrictions in the availability of cells due to their isolation and expansion as well as the complex and costly large-scale production. In the same manner, the cryopreservation might cause deleterious effects that affect the biological activity of the cells and a medical professional should conduct the cell administration. In addition, different studies report variability in the results due to the inconsistency in the methods that they used (extraction protocols, cultivation, expansion and administration). The investigators' recent studies in mice with skin lesions, particularly type 1 diabetes, have shown that the presence of the cells is not necessary to promote skin regeneration and the administration of dac-MSCs is sufficient to stimulate would healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dac-MSCs and Fitostimoline | Experimental | Other: dac-MSCs, Drug: FitostimolineIntradermic 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 comparator | Other: MSCs, Drug: FitostimolineIntradermic 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 comparator | Drug: FitostimolineTopical application of fitostimoline every other day |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dac-MSCsAlso: Cell-free therapyCell-free therapy | Other | dac-MSCs and Fitostimoline |
| MSCsAlso: Cell-based therapyCell-based therapy | Other | MSCs and Fitostimoline |
| FitostimolineAlso: Triticum vulgareTriticum vulgare | Drug | Fitostimoline, MSCs and Fitostimoline, dac-MSCs and Fitostimoline |
Primary outcome
Wound size change
Time frame: One year
Wound size will be assessed using a SilhouetteMobile camera (digital planimetry)
3 secondary outcomes
Granulation tissue percentage
Time frame: One year
Pigmentation change
Time frame: One year
Presence of Exudate
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia L Sossa-Melo, MD principal investigator
Universidad Autónoma de Bucaramanga
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dac-MSCs, MSCs and Fitostimoline in people with Foot Ulcer, Diabetic, run by Universidad Autónoma de Bucaramanga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia L Sossa-Melo, MD (+57 7 643 6261 ext. 587, claudiasossa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound size change (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.