Diabetic Foot UlcerPhase 3ASCENDNCT05095389
Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers
A Phase 3 study testing ADRCs in people with Diabetic Foot Ulcer, run by Paracrine, INC..
Trial summary
A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU). Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- ADRCs
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2023to Jul 2025
- Phase
- Phase 3
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1D or T2D
- Diabetic Foot Ulcer, from 1 to 12 months in duration
- Wagner Grade 1 or Superficial 2
- Adequate perfusion
- Able to undergo liposuction
Who cannot join
- Diabetic Foot Ulcer penetrates to capsule, tendon, or bone
- Active infection
- Non-diabetic neuropathy
- Significant cardiovascular event within 6 months before screening
About this study
Official title: Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Diabetic Foot Ulcers: a Prospective, Double-blind, Multi-center, Randomized, Parallel-group Study
A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).
Read the detailed description
Subjects will have at least one diabetic foot ulcer between 1 cm2 and 16 cm2 area that remains open despite at least 30 days of DFU care and will need debridement as a part of their care.
Subjects will be randomly assigned to one of two groups (ADRC Group will receive standard care plus ADRC, and Control Group will receive standard care plus matched placebo).
ADRCs will be harvested from a small volume liposuction performed on the same day as, but prior to, the debridement procedure. Fat harvest will occur through small volume (approximately 100-200 mL) liposuction prior to the surgical debridement procedure on the same day as the planned autograft procedure.
The lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for application to an autograft site. Cells will be delivered via direct injection (minimal wound penetration with a 22 gauge needle, total volume 5 mL) into the DFU (injected around the circumference and applied to the base of the ulcer).
- Conditions
- Diabetic Foot Ulcer
- Being tested
- ADRCs, standard care, Placebo
- Keywords
- Diabetic Foot Ulcer, DFU, Non-healing Foot Ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRCsDevice
Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer
standard careOther
standard care
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Standard Care plus ARDCs | Experimental | * All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure.
* All patients will receive standard care for their Diabetic Foot Ulcer.
* Additionally, patients randomized to the ADRC arm will receive ADRCs Receives: Device: ADRCs; Other: standard care |
| Standard Care plus Placebo | Active comparator | * All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure.
* All patients will receive standard care for their Diabetic Foot Ulcer.
* Additionally, patients randomized to the Control arm will receive Placebo Receives: Other: standard care; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFU Closure Rate
The rate of closure at 12 Weeks
Measured: 12 Weeks
Secondary outcomes (1)
Percent Reduction of Wound Area
Percent Reduction of Wound Area from Baseline to 12 Weeks for Ulcers not Completely Healed
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start28 Feb 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Parallel-Group, Double-Blind, Placebo Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paracrine, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095389
- Sponsor's protocol ID
- 2021-01
- Acronym
- ASCEND
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD/PHI will be made available
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Diabetic Foot Ulcers: a Prospective, Double-blind, Multi-center, Randomized, Parallel-group Study
- ClinicalTrials.gov ID
- NCT05095389
- Acronym / sponsor ID
- ASCEND / 2021-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer, DFU, Non-healing Foot Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Paracrine, INC.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Oct 2021 (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.
A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).
Detailed description
Subjects will have at least one diabetic foot ulcer between 1 cm2 and 16 cm2 area that remains open despite at least 30 days of DFU care and will need debridement as a part of their care.
Subjects will be randomly assigned to one of two groups (ADRC Group will receive standard care plus ADRC, and Control Group will receive standard care plus matched placebo).
ADRCs will be harvested from a small volume liposuction performed on the same day as, but prior to, the debridement procedure. Fat harvest will occur through small volume (approximately 100-200 mL) liposuction prior to the surgical debridement procedure on the same day as the planned autograft procedure.
The lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for application to an autograft site. Cells will be delivered via direct injection (minimal wound penetration with a 22 gauge needle, total volume 5 mL) into the DFU (injected around the circumference and applied to the base of the ulcer).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Parallel-Group, Double-Blind, Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Standard Care plus ARDCs | Experimental | Device: ADRCs, Other: standard care* All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. * All patients will receive standard care for their Diabetic Foot Ulcer. * Additionally, patients randomized to the ADRC arm will receive ADRCs |
| Standard Care plus Placebo | Active comparator | Other: standard care, Other: Placebo* All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. * All patients will receive standard care for their Diabetic Foot Ulcer. * Additionally, patients randomized to the Control arm will receive Placebo |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- T1D or T2D
- Diabetic Foot Ulcer, from 1 to 12 months in duration
- Wagner Grade 1 or Superficial 2
- Adequate perfusion
- Able to undergo liposuction
Key exclusion criteria (4 listed)
- Diabetic Foot Ulcer penetrates to capsule, tendon, or bone
- Active infection
- Non-diabetic neuropathy
- Significant cardiovascular event within 6 months before screening
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 |
|---|---|---|
| ADRCsAdministration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer | Device | Standard Care plus ARDCs |
| standard carestandard care | Other | Standard Care plus ARDCs, Standard Care plus Placebo |
| Placeboplacebo | Other | Standard Care plus Placebo |
Primary outcome
DFU Closure Rate
Time frame: 12 Weeks
The rate of closure at 12 Weeks
1 secondary outcome
Percent Reduction of Wound Area
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No. No IPD/PHI will be made available
Related trials for Diabetic Foot Ulcer
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ADRCs in people with Diabetic Foot Ulcer, run by Paracrine, INC..
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 5 inclusion and 4 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 28 Sep 2022. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFU Closure Rate (time frame: 12 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 28 Sep 2022.