Diabetic Foot UlcersNCT02402374
Evaluate the Safety and Efficacy of RegenKit Autologous PRP Gel for the Treatment of Diabetic Foot Ulcer
A study testing Autologous platelet rich plasma gel in people with Diabetic Foot Ulcers, run by Regen Lab SA at 1 site in United States.
Trial summary
Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a larger randomized, placebo-controlled clinical trial will be useful to determine whether platelet-rich plasma is safe and effective for… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Autologous platelet rich plasma gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2018to 30 Dec 2020
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who in the opinion of the Investigator, are capable of understanding and complying with protocol requirements
- Patients or, when applicable, their legal representatives, sign and dates a written IFC and/or any required privacy authorization prior to the initiation of any study procedure
- Patients aged 18 to 95 (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
- Patients with glycated hemoglobin (HbA1C) less than or equal to 12%
- Patients having ulcers which meet the following criteria:
- Ulcer should not be infected as determined by clinical examination
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- Ulcer duration of 4 weeks or longer
- Ulcer area (length x width) of between 1.5 cm2 and 20 cm2
- Full-thickness ulcer of Grade 1 or Grade 2 as per Wagner's classification system
- Ulcer has undergone recent debridement (2 weeks prior to screening)
- Post-debridement ulcer is free of necrotic debris, foreign bodies, sinus tracts, tunneling, and undermining and is comprised of healthy vascularized tissue
- Patients with Charcot deformity, the wound should be free of acute changes and, in the opinion of Investigator, should have undergone appropriate structural consolidation (the affected charcot fractures will have been fused together and should be sufficiently stable to allow the patient to weight-bear)
- Patients having adequate circulation to the foot as documented by either:
- Ankle Brachial Index (ABI) between 0.60 and 1.30, or
- Patients with falsely elevated ABI values (equal to or greater than 1.30) due to non-compressible ankle vessels:
- i)Toe Brachial Index (TBI) equal to or greater than 0.50 or, ii)TBI is not available (toe is absent, wounds are present, or investigative site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g duplex imaging or normal pulse volume recording)
- Patients who agree to conform to the off-loading requirements
- Patients of childbearing age must agree to use a method of contraception or agree to abstain from sexual intercourse throughout the study
Who cannot join
- Patients with ulcers having an active infection with/without purulent discharge
- Patients with ulcers with exposed bone or associated with osteomyelitis
- Patients with target limb cellulitis, or ischemic or gangrenous ulcers
- Patients who have undergone, in the 2-week period prior to enrollment, treatment for DFU with any advanced treatment modality other than standard of care, such as growth factors, skin substitutes or other biological treatments
- Female patients who are pregnant or lactating
- Patients diagnosed with cancer, undergoing chemotherapy, except basal cell carcinoma
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- Patients with wounds caused by basal cell carcinoma or due to basal cell carcinoma excision
- Patients with wounds due to malignancy
- Patients having had any revascularization surgery within the 4-week period prior to signing the ICF
- Patients with renal failure requiring dialysis
- Patients with platelet count outside of the normal range of 150-400 x 1000/uL
- Patients with a history of allergy to one of tested components
- Patients with a history of bleeding disorders
- Patients suffering from skin or blood cancers, or having suffered in the past from such cancers and not having, certification of a total remission
- Patients presenting skin lesions potentially caused by abnormal cellular proliferation process (history of being cancerous)
- Patients with a history of any condition, physical examination finding, or clinical laboratory finding, giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational agent or may confound the interpretation of study results or might render the patient at high risk for treatment complications
- Patients with active Charcot or other structural deformity that would prevent adequate off-loading of the study foot
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled, Blind-assessor Study to Evaluate the Safety and Efficacy of Autologous Platelet Rich Plasma Gel Prepared With the RegenKit-BCT Plus Family of Kits for the Treatment of Diabetic Foot Ulcer
Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a larger randomized, placebo-controlled clinical trial will be useful to determine whether platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).
Read the detailed description
Evaluate the safety and efficacy of RegenKit autologous PRP Gel for the treatment of diabetic foot ulcer is a randomized, placebo controlled, blind-assessor study. One hundred and seventy four patients will be treated, 87 patients receiving treatment arm and 87 patients receiving placebo. The primary endpoint is to evaluate proportion of patients with complete wound closure at week 16 when treated with autologous platelet rich plasma gel compared to the proportion of control (saline gel) treated patients with complete wound closure at the same time-point.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Autologous platelet rich plasma gel, Placebo
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelet rich plasma gelDevice
PRP gel application to exuding wounds, such as leg ulcers, pressure ulcers, and diabetic foot ulcers and for the management of mechanically- or surgically-debrided wounds
PlaceboDevice
Placebo control arm will be receiving commercial formulations of pre-prepared saline gel.
| Study group | Role | What they receive |
|---|---|---|
| PRP gel | Experimental | Autologous platelet rich plasma gel Receives: Device: Autologous platelet rich plasma gel |
| Placebo | Placebo comparator | Saline gel Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete wound closure
Proportion of patients with complete wound closure at week 16 when treated with autologous platelet rich plasma gel compared to the proportion of control (saline gel)-treated patients with complete wound closure at the same time-point.
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 posted30 Mar 2015 (estimated)
- Study start12 Apr 2018
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regen Lab SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RegenLab USA LLC
- Responsible party
- Sponsor
- Investigators
- Alisha Oropallo, MD, Principal investigator, Northwell Health, Comprehensive Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402374
- Sponsor's protocol ID
- 2014-WH-02
- Status last verified
- Dec 2019
- First submitted
- 25 Mar 2015
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Institution and the Principal Investigator are free to publish, present, or use any data and results arising out of this Study, provided that such publication does not disclose any of Sponsor's Confidential Information. Sponsor shall be able to present data and results at symposia, national or regional professional meetings, and publish in journals, theses or dissertations, or otherwise of its own choosing. In the event that the Principal Investigator fails to submit a formal academic publication within twelve (12) months following completion of the Study, the Sponsor is entitled to prepare a publication based on the data and results. Such proposed publication will be submitted to the Institution for review and comment at the least thirty (30) calendar days before submission for publication.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Blind-assessor Study to Evaluate the Safety and Efficacy of Autologous Platelet Rich Plasma Gel Prepared With the RegenKit-BCT Plus Family of Kits for the Treatment of Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT02402374
- Acronym / sponsor ID
- 2014-WH-02
- Conditions
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Regen Lab SAIndustry (pharma, biotech, devices)
- Collaborators
- RegenLab USA LLC
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 30 Mar 2015 (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.
Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a larger randomized, placebo-controlled clinical trial will be useful to determine whether platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).
Detailed description
Evaluate the safety and efficacy of RegenKit autologous PRP Gel for the treatment of diabetic foot ulcer is a randomized, placebo controlled, blind-assessor study. One hundred and seventy four patients will be treated, 87 patients receiving treatment arm and 87 patients receiving placebo. The primary endpoint is to evaluate proportion of patients with complete wound closure at week 16 when treated with autologous platelet rich plasma gel compared to the proportion of control (saline gel) treated patients with complete wound closure at the same time-point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP gel | Experimental | Device: Autologous platelet rich plasma gelAutologous platelet rich plasma gel |
| Placebo | Placebo comparator | Device: PlaceboSaline gel |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients who in the opinion of the Investigator, are capable of understanding and complying with protocol requirements
- Patients or, when applicable, their legal representatives, sign and dates a written IFC and/or any required privacy authorization prior to the initiation of any study procedure
- Patients aged 18 to 95 (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
- Patients with glycated hemoglobin (HbA1C) less than or equal to 12%
- Patients having ulcers which meet the following criteria:
Key exclusion criteria (17 listed)
- Patients with ulcers having an active infection with/without purulent discharge
- Patients with ulcers with exposed bone or associated with osteomyelitis
- Patients with target limb cellulitis, or ischemic or gangrenous ulcers
- Patients who have undergone, in the 2-week period prior to enrollment, treatment for DFU with any advanced treatment modality other than standard of care, such as growth factors, skin substitutes or other biological treatments
- Female patients who are pregnant or lactating
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 |
|---|---|---|
| Autologous platelet rich plasma gelPRP gel application to exuding wounds, such as leg ulcers, pressure ulcers, and diabetic foot ulcers and for the management of mechanically- or surgically-debrided wounds | Device | PRP gel |
| PlaceboPlacebo control arm will be receiving commercial formulations of pre-prepared saline gel. | Device | Placebo |
Primary outcome
Proportion of patients with complete wound closure
Time frame: 16 weeks
Proportion of patients with complete wound closure at week 16 when treated with autologous platelet rich plasma gel compared to the proportion of control (saline gel)-treated patients with complete wound closure at the same time-point.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Yes. The Institution and the Principal Investigator are free to publish, present, or use any data and results arising out of this Study, provided that such publication does not disclose any of Sponsor's Confidential Information. Sponsor shall be able to present data and results at symposia, national or regional professional meetings, and publish in journals, theses or dissertations, or otherwise of its own choosing. In the event that the Principal Investigator fails to submit a formal academic publication within twelve (12) months following completion of the Study, the Sponsor is entitled to prepare a publication based on the data and results. Such proposed publication will be submitted to the Institution for review and comment at the least thirty (30) calendar days before submission for publication.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Alisha Oropallo, MD principal investigator
Northwell Health, Comprehensive Wound Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous platelet rich plasma gel in people with Diabetic Foot Ulcers, run by Regen Lab SA at 1 site in United States.
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 18 inclusion and 17 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 8 Oct 2020. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Proportion of patients with complete wound closure (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 8 Oct 2020.