Diabetic Foot Ulcer Associated With Type II Diabetes MellitusPhase 2NCT05234086
Cell Therapy for Diabetic Foot Ulcer
A Phase 2 study testing InbioDerm + C plus advanced healing and Advanced healing in people with Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus and Wound Heal, run by Instituto para el Desarrollo Biotecnológico y la Innovación S.A. at 1 site in Chile.
Trial summary
Diabetes is a highly prevalent chronic disease that affects a large part of the world's population. Among the most costly complications is the diabetic foot ulcer, where its decompensation can result in limb amputation, a risk 10 to 20 times more frequent for diabetic population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus, Wound Heal
- What is being tested?
- InbioDerm + C plus advanced healing and Advanced healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 2 Jan 2020to 2 Sep 2022
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old and under 75 years old.
- Patient diagnosed with DM type II.
- Patient with negative pregnancy test.
- Ulcer size with area between 1 cm2 and 12 cm2.
- Ulcer with Wagner grade II classification with less than 50% slough and no tendon exposure, validated by an external specialist after ulcer debridement.
- Ulcer age ≥ at one month.
- Patients with palpable posterior tibial and pedial pulse
Who cannot join
- Patients with non-diabetic ulcers.
- Toe ulcers.
- Patient with grade IV and V renal insufficiency.
- Pregnant or breastfeeding women, or those who are planning to conceive children.
- Clinical evidence of infection.
- Any condition or circumstance that might interfere with adherence to the treatment regimen (compliance with scheduled visits, psychiatric disorders, or drug and/or alcohol abuse)
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- History of hepatitis B or hepatitis C and HIV (by internal laboratory biosafety protocols)
- Allergy to penicillin, streptomycin, and gentamicin
- Subjects undergoing treatment with immunosuppressants and corticoids.
- Subjects on anticoagulant treatment with acenocoumarol and warfarin.
- Having received any experimental treatment in the last three months (drug, biological product, medical device or cell therapy), except for the use of vaccines administered against COVID-19 (e.g. mRNA technologies, viral vector or inactivated virus).
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Centro de Salud Familiar de Villa Alemana
Villa Alemana, Valparaiso, 2550880
Franco Ahumada, MD, 56965487096, franco.ahumada@gmail.com
About this study
Official title: Randomized, Controlled Phase II Clinical Study to Evaluate Superiority of "InbioDerm+C" Autologous Stem Cell-Based Therapy Plus Advanced Healing Compared With Advanced Healing in Diabetic Foot Ulcer Patients
Diabetes is a highly prevalent chronic disease that affects a large part of the world's population. Among the most costly complications is the diabetic foot ulcer, where its decompensation can result in limb amputation, a risk 10 to 20 times more frequent for diabetic population. Two underlying pathophysiological mechanisms are mainly identified: neuropathy and problems associated with vasculature and blood supply, in addition to the incidence of infections, which further impairs prognosis. Skin regeneration involves several overlapping and consecutive stages, which in the case of a diabetic patient are altered.
Although healing protocols have been significantly improved at the country level, and there is also a large amount of medical supplies for treatment of these wounds, there are still patients with ulcers refractory to this care that end in amputation. In response to this, new treatments have emerged that use biomaterials and cells of the patient himself, which attempt to emulate the architecture and functionality of normal tissue. Cell therapy has gained strength in recent years, with more and more studies indicating the positive effect of cell application on healing of chronic wounds with underlying pathologies, such as diabetes.
The product to be evaluated corresponds to a combined medical device, which conveys a cellular therapy, known as InbioDerm+C. The purpose of this Phase II clinical study is to determine whether InbioDerm+C treatment plus advanced healing is equal to or superior to advanced healing in a diabetic population with Wagner II grade foot ulcer treated in Villa Alemana primary care family centers, Las Américas, Juan Bautista Bravo Vega and Eduardo Frei.
- Being tested
- InbioDerm + C plus advanced healing, Advanced healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InbioDerm + C plus advanced healingCombination product
For patients who are assigned to experimental treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section, through an enzymatic process and cell proliferation for a period of approximately fourteen days, the cells that are integrated in the InbioDerm+C will be obtained and used to treat the foot ulcer.
Advanced healingProcedure or surgery
Patients who are assigned to active comparator correspond to the control treatment, which will be received advanced healing.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Healing | Active comparator | Activities related to wound washing, microbiological load control, care of peri-ulcer tissue and application of wound healing products in accordance to condition of the ulcer Receives: Procedure: Advanced healing |
| InbioDerm + C plus advanced healing | Experimental | For patient who are assigned treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section and through an enzymatic process with cell proliferation, skin cells will be obtained that will be integrated into de the InbioDerm+C, then will be apply to the patients with the advanced wound healing every fourteen days in accordance application program. Receives: Combination Product: InbioDerm + C plus advanced healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with completely closed ulcers
The principal investigation and external evaluator will assess every fifteen days the wound closure status.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start2 Jan 2020
- Primary completionMay 2022 (estimated)
- Study completion2 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer Associated With Type II Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Corporación de Fomento de la Producción, Chile
- Responsible party
- Principal investigator, Soledad Herrera, Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
- Investigators
- Franco Ahumada, Principal investigator, Centro de Salud Familiar Villa Alemana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234086
- Sponsor's protocol ID
- INBIO EC 201903
- Status last verified
- Feb 2022
- First submitted
- 31 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Phase II Clinical Study to Evaluate Superiority of "InbioDerm+C" Autologous Stem Cell-Based Therapy Plus Advanced Healing Compared With Advanced Healing in Diabetic Foot Ulcer Patients
- ClinicalTrials.gov ID
- NCT05234086
- Acronym / sponsor ID
- INBIO EC 201903
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto para el Desarrollo Biotecnológico y la Innovación S.A.University, hospital or other
- Collaborators
- Corporación de Fomento de la Producción, Chile
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- 2 Sep 2022 (estimated)
- First posted
- 10 Feb 2022 (actual)
- 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.
Diabetes is a highly prevalent chronic disease that affects a large part of the world's population. Among the most costly complications is the diabetic foot ulcer, where its decompensation can result in limb amputation, a risk 10 to 20 times more frequent for diabetic population. Two underlying pathophysiological mechanisms are mainly identified: neuropathy and problems associated with vasculature and blood supply, in addition to the incidence of infections, which further impairs prognosis. Skin regeneration involves several overlapping and consecutive stages, which in the case of a diabetic patient are altered.
Although healing protocols have been significantly improved at the country level, and there is also a large amount of medical supplies for treatment of these wounds, there are still patients with ulcers refractory to this care that end in amputation. In response to this, new treatments have emerged that use biomaterials and cells of the patient himself, which attempt to emulate the architecture and functionality of normal tissue. Cell therapy has gained strength in recent years, with more and more studies indicating the positive effect of cell application on healing of chronic wounds with underlying pathologies, such as diabetes.
The product to be evaluated corresponds to a combined medical device, which conveys a cellular therapy, known as InbioDerm+C. The purpose of this Phase II clinical study is to determine whether InbioDerm+C treatment plus advanced healing is equal to or superior to advanced healing in a diabetic population with Wagner II grade foot ulcer treated in Villa Alemana primary care family centers, Las Américas, Juan Bautista Bravo Vega and Eduardo Frei.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Healing | Active comparator | Procedure: Advanced healingActivities related to wound washing, microbiological load control, care of peri-ulcer tissue and application of wound healing products in accordance to condition of the ulcer |
| InbioDerm + C plus advanced healing | Experimental | Combination Product: InbioDerm + C plus advanced healingFor patient who are assigned treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section and through an enzymatic process with cell proliferation, skin cells will be obtained that will be integrated into de the InbioDerm+C, then will be apply to the patients with the advanced wound healing every fourteen days in accordance application program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient over 18 years old and under 75 years old.
- Patient diagnosed with DM type II.
- Patient with negative pregnancy test.
- Ulcer size with area between 1 cm2 and 12 cm2.
- Ulcer with Wagner grade II classification with less than 50% slough and no tendon exposure, validated by an external specialist after ulcer debridement.
Key exclusion criteria (11 listed)
- Patients with non-diabetic ulcers.
- Toe ulcers.
- Patient with grade IV and V renal insufficiency.
- Pregnant or breastfeeding women, or those who are planning to conceive children.
- Clinical evidence of 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 |
|---|---|---|
| InbioDerm + C plus advanced healingFor patients who are assigned to experimental treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section, through an enzymatic process and cell proliferation for a period of approximately fourteen days, the cells that are integrated in the InbioDerm+C will be obtained and used to treat the foot ulcer. | Combination product | InbioDerm + C plus advanced healing |
| Advanced healingPatients who are assigned to active comparator correspond to the control treatment, which will be received advanced healing. | Procedure or surgery | Advanced Healing |
Primary outcome
Proportion of patients with completely closed ulcers
Time frame: 16 weeks
The principal investigation and external evaluator will assess every fifteen days the wound closure status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- 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.
Franco Ahumada principal investigator
Centro de Salud Familiar Villa Alemana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing InbioDerm + C plus advanced healing and Advanced healing in people with Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus and Wound Heal, run by Instituto para el Desarrollo Biotecnológico y la Innovación S.A. at 1 site in Chile.
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 11 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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 Soledad Herrera (56966083093, soledadherrera@inbiocriotec.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with completely closed ulcers (time frame: 16 weeks). 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 10 Feb 2022.