Diabetic Foot UlcerPhase 1/2NCT02989961
Safety and Efficacy of Resticutis Compared to Platelet-Poor Plasma for Treating Diabetic Foot Ulcers
A Phase 1/2 study testing Resticutis and Platelet-Poor Plasma (PPP) in people with Diabetic Foot Ulcer, run by Hanan Jafar.
Trial summary
The purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Resticutis and Platelet-Poor Plasma (PPP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2013to Nov 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with Type II Diabetes mellitus between the ages of 18 and 70 with an ulcer with at least 4 weeks duration.
- Hb1c of less than 13 %.
- Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces), and wound area (length*width) measurement between 0.5 cm^2 and 20 cm^2, inclusive.
- Wounds located under a Charcot deformity has to be free of acute changes and went through appropriate structural consolidation.
- Wagner Grade II or III ulcer.
- The protocol requires that post-debridement, the ulcer would be free of necrotic debris, foreign bodies, or sinus tracts.
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- Non invasive vascular testing Ankle Brachial Index (ABI).
- Physical examination (Including a Semmes-Weinstein monofilament test for neuropathy).
- Blood tests to be obtained (CBC, Hb1c)
- Approved, informed, signed consent to be obtained from each patient.
Who cannot join
- Patient currently enrolled in another investigative device or drug trial or previously enrolled (within the last 30 days) in an investigative research of a device or a pharmaceutical agent.
- Ulcer area decreased > 50% during the seven-day screening period.
- Ulcer is due to a non-diabetic etiology.
- Evidence of gangrene in ulcer or on any part of the foot.
- Patient is currently receiving or has received radiation or chemotherapy within the last 3 months of randomization.
- Patient has received growth factor therapy within 7 days of randomization.
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- Screening platelets count < 100* 10^9/L.
- Patient is undergoing renal dialysis, or has a known immune insufficiency, known abnormal platelets activation disorder (i.e. Grey Platelet Syndrome, Liver Disease, Active Cancer), eating/nutritional, hematologic, collagen vascular disease, rheumatic disease, or bleeding disorder.
- History of peripheral vascular repair within 30 days of randomization.
- Patient is known to have a physiological, developmental, physical, emotional, or social disorder, or any other situation that may interfere with their compliance with the study requirements and/or the healing of the ulcer.
- History of alcohol or drug abuse within the last year prior to randomization.
- Patient has inadequate venous access for blood withdraw.
About this study
Official title: Autologous Intra-lesional Injection of Resticutis Compared to Platelet-Poor Plasma to Improve Healing of Wagner's Grade II/III Diabetic Foot Ulcers (Neuropathic/Neuro-Iscemic)
The purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator.
Read the detailed description
Grade II and III (According to Wagner's classification system of Ulcer severity) are considered to be of the most common complications associated with Diabetes, which are mostly hard to heal using the conventional treatment methods which by consequence severely affects the quality and lifestyle of the diabetes patient.
It's thought that the application of Autologous activated platelets "Resticutis" which secretes huge amounts of growth factors is capable of giving better results of which are: the stimulation of the healing process that includes contraction, granulation, tissue formation and epithelialization of the diabetic foot ulcer.
Resticutis is obtained from an autologous 20 mL peripheral blood withdrawn in tubes containing 3.8% Sodium Citrate. Blood is then centrifuged to obtain Platelet-Rich Plasma -PRP- as per established method. PRP is then activated in a closed system by physical methods to obtain a final product of 5 mL of Resticutis which is injected intra-lesionally at ulcer margins per each session of therapy.
It's hypothesized that a total of six injections throughout the period of the treatment are enough to achieve full closure of the DFU. The injections are given on days: 0,14,28,42,56, and 70 of the treatment period.
The consenting patients will be randomized into 2 groups: One group will be given Resticutis, and the second one Platelet-Poor Plasma PPP as placebo. If patients in PPP group didn't achieve full healing after four-six injections, they're given a two weeks rest after which they are given Resticutis instead.
This is mainly a phase 1 safety study, which means no formal statistical analysis will be applied to any of the data. Safety assessment will depend on the association of any adverse events during the course of the study, and efficacy as a secondary objective will be assessed by observing the healing time of DFUs.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Resticutis, Platelet-Poor Plasma (PPP)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResticutisOther
Also called Actiplate 1
Autologous, Activated-Platelets type of Preparation
Platelet-Poor Plasma (PPP)Other
A preparation of low platelet plasma obtained by a high-speed centrifugation step.
| Study group | Role | What they receive |
|---|---|---|
| A-Resticutis | Experimental | Autologous, Activated-Platelets type of preparation. Receives: Other: Resticutis |
| C-Platelet-Poor Plasma PPP | Placebo comparator | Platelet-Poor Plasma type of preparation achieved by centrifugation of blood samples at high speed conditions. Resticutis is administered instead if the patient doesn't achieve full healing after 6 injections. Receives: Other: Resticutis; Other: Platelet-Poor Plasma (PPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection
Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.
Measured: 2 months
Secondary outcomes (1)
Assess the efficacy of autologous Resticutis injection by clinical examination
To determine short term speed and effectiveness of autologous Resticutis as a platelet lysate derivative on the healing of diabetic foot ulceration compared with Platelet Poor Plasma by measuring the healing time.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start15 Nov 2013
- Primary completion13 Mar 2018
- Study completionNov 2019 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanan Jafar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanan Jafar, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989961
- Sponsor's protocol ID
- Resticutis.UJCTC
- Status last verified
- Apr 2019
- First submitted
- 29 Nov 2016
- Last updated
- 10 Apr 2019
- 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 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Intra-lesional Injection of Resticutis Compared to Platelet-Poor Plasma to Improve Healing of Wagner's Grade II/III Diabetic Foot Ulcers (Neuropathic/Neuro-Iscemic)
- ClinicalTrials.gov ID
- NCT02989961
- Acronym / sponsor ID
- Resticutis.UJCTC
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hanan JafarUniversity, hospital or other
- Study start
- 15 Nov 2013 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 12 Dec 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 purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator.
Detailed description
Grade II and III (According to Wagner's classification system of Ulcer severity) are considered to be of the most common complications associated with Diabetes, which are mostly hard to heal using the conventional treatment methods which by consequence severely affects the quality and lifestyle of the diabetes patient.
It's thought that the application of Autologous activated platelets "Resticutis" which secretes huge amounts of growth factors is capable of giving better results of which are: the stimulation of the healing process that includes contraction, granulation, tissue formation and epithelialization of the diabetic foot ulcer.
Resticutis is obtained from an autologous 20 mL peripheral blood withdrawn in tubes containing 3.8% Sodium Citrate. Blood is then centrifuged to obtain Platelet-Rich Plasma -PRP- as per established method. PRP is then activated in a closed system by physical methods to obtain a final product of 5 mL of Resticutis which is injected intra-lesionally at ulcer margins per each session of therapy.
It's hypothesized that a total of six injections throughout the period of the treatment are enough to achieve full closure of the DFU. The injections are given on days: 0,14,28,42,56, and 70 of the treatment period.
The consenting patients will be randomized into 2 groups: One group will be given Resticutis, and the second one Platelet-Poor Plasma PPP as placebo. If patients in PPP group didn't achieve full healing after four-six injections, they're given a two weeks rest after which they are given Resticutis instead.
This is mainly a phase 1 safety study, which means no formal statistical analysis will be applied to any of the data. Safety assessment will depend on the association of any adverse events during the course of the study, and efficacy as a secondary objective will be assessed by observing the healing time of DFUs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-Resticutis | Experimental | Other: ResticutisAutologous, Activated-Platelets type of preparation. |
| C-Platelet-Poor Plasma PPP | Placebo comparator | Other: Resticutis, Other: Platelet-Poor Plasma (PPP)Platelet-Poor Plasma type of preparation achieved by centrifugation of blood samples at high speed conditions. Resticutis is administered instead if the patient doesn't achieve full healing after 6 injections. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- People with Type II Diabetes mellitus between the ages of 18 and 70 with an ulcer with at least 4 weeks duration.
- Hb1c of less than 13 %.
- Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces), and wound area (length*width) measurement between 0.5 cm^2 and 20 cm^2, inclusive.
- Wounds located under a Charcot deformity has to be free of acute changes and went through appropriate structural consolidation.
- Wagner Grade II or III ulcer.
Key exclusion criteria (12 listed)
- Patient currently enrolled in another investigative device or drug trial or previously enrolled (within the last 30 days) in an investigative research of a device or a pharmaceutical agent.
- Ulcer area decreased > 50% during the seven-day screening period.
- Ulcer is due to a non-diabetic etiology.
- Evidence of gangrene in ulcer or on any part of the foot.
- Patient is currently receiving or has received radiation or chemotherapy within the last 3 months of randomization.
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 |
|---|---|---|
| ResticutisAlso: Actiplate 1Autologous, Activated-Platelets type of Preparation | Other | A-Resticutis, C-Platelet-Poor Plasma PPP |
| Platelet-Poor Plasma (PPP)A preparation of low platelet plasma obtained by a high-speed centrifugation step. | Other | C-Platelet-Poor Plasma PPP |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection
Time frame: 2 months
Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.
1 secondary outcome
Assess the efficacy of autologous Resticutis injection by clinical examination
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- 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.
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 1/2 study testing Resticutis and Platelet-Poor Plasma (PPP) in people with Diabetic Foot Ulcer, run by Hanan Jafar.
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 10 inclusion and 12 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 Apr 2019. 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. 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.
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?
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection (time frame: 2 months). 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 Apr 2019.