Diabetic Foot UlcerPhase 1/2NCT02972528
The Use of Allogenic Platelet Rich Plasma for the Treatment of Diabetic Foot Ulcer
A Phase 1/2 study testing Platelet Lysate and Platelet Poor Plasma in people with Diabetic Foot Ulcer, run by Hanan Jafar at 1 site in Jordan.
Trial summary
Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed with Diabetic Foot Ulcer (DFU). 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?
- Platelet Lysate and Platelet Poor Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJordan
- Study dates
- 3 Feb 2018to Sep 2020
- 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
- Persons with type 1 or type 2 diabetes between the ages of 18 and 70 with an ulcer of at least 4 weeks duration
- HemoglobinA1C (HbA1c) < 12
- Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces); and wound area (length x width) measurement between 2 cm2 and 20 cm2, inclusive.
- Wounds located under a Charcot deformity had to be free of acute changes and must have under gone appropriate structural consolidation.
- The index ulcer had to be clinically non-infected and full - thickness without exposure of bone, ligaments, or tendons.
- The protocol requires that post debridement the ulcer would be free of necrotic debris, foreign bodies or sinus tracts.
Show all 11Show fewer
- Non- invasive vascular testing ankle brachial index (ABI).
- Physical examination (including a Semmes-Weinstein monofilament test for neuropathy)
- Blood tests to be obtained Complete Blood Count and HbA1c.
- Approved, informed, signed consent.
- Negative test for Hepatitis C (HC), Hepatitis B (HB), Human Immunodeficiency Virus 1 and 2 (HIVI and II), Venereal Disease Research Laboratory (VDRL).
Who cannot join
- Patient currently enrolled in another investigational device or drug trial or previously enrolled (within last 30 days) in investigative research of a device or pharmaceutical agent.
- Ulcer decreased ≥50% in area during 7-day screening period.
- Ulcer is due to non-diabetic etiology.
- Patient's blood vessels are non-compressible for ABI testing.
- Evidence of gangrene in ulcer or on any part of the foot.
- Patient has radiographic evidence consistent with diagnosis of acute Charcot foot.
Show all 19Show fewer
- Patient is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- Patient has received growth factor therapy within 7 days of randomization.
- Screening hemoglobin <10.5 mg/dL.
- Screening platelet count < 100 x 109/L.
- Patient is undergoing renal dialysis, has known immune insufficiency, known abnormal platelet activation disorders - ie, gray platelet syndrome, liver disease, active cancer (except remote basal cell of the skin), eating/ nutritional,hematologic, collagen vascular disease, rheumatic disease, or bleeding disorders.
- History of peripheral vascular repair within the 30 days of randomization
- Patient has known or suspected osteomyelitis.
- Surgical correction (other than debridement) required for ulcer to heal.
- Index ulcer has exposed tendons, ligaments, muscle, or bone.
- Patient is known to have a psychological, developmental, physical, emotional, or social disorder, or any other situation that may interfere with compliance with study requirements and/or healing of the ulcer
- History of alcohol or drug abuse within the last year prior to randomization.
- Patient has inadequate venous access for blood draw.
- Positive test for HC, HB, HIVI and II, VDRL.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Cell Therapy Center
Amman, 11942
Abdalla Awidi, MD, 0096265355000 ext. 23960, abdalla.awidi@gmail.com
About this study
Official title: Allogeneic Defibrinated Platelet Rich Plasma Lysate for the Healing of Chronic Diabetic Foot Ulcer
Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed with Diabetic Foot Ulcer (DFU).
Read the detailed description
In this study, allogenic, defibrinated platelet rich plasma lysate will be used as a direct injection into the periphery of diabetic chronic foot ulcers which have not healed using standard of care. Investigators anticipate a significant response in treated individuals measured by the percentage of skin restoration achieved.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Platelet Lysate, Platelet Poor Plasma
- Keywords
- DFU, Diabetic Foot Ulcer, Diabetes, Platelet Rich Plasma
- 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.
Platelet LysateBiological
Direct injection of allogenic Platelet Lysate
Platelet Poor PlasmaBiological
Direct injection of allogenic Platelet Poor Plasma
| Study group | Role | What they receive |
|---|---|---|
| Platelet Lysate | Active comparator | Patients will receive 5ml peri-lesional injections of Platelet Lysate at weekly intervals, for 4 consecutive times (week 0,1,2,3). Receives: Biological: Platelet Lysate |
| Platelet Poor Plasma | Placebo comparator | Patients will receive 5ml peri-lesional injections of Platelet Poor Plasma at weekly intervals, for 4 consecutive times (week 0,1,2,3). Receives: Biological: Platelet Poor Plasma |
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: 3 months
Secondary outcomes (1)
Assess the efficacy of allogenic Platelet Lysate injection by clinical examination
To determine short term speed and effectiveness of allogeneic, platelet rich plasma lysate on the healing of diabetic foot ulceration compared with Platelet Poor Plasma by measuring the diameter of ulcers.
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 posted23 Nov 2016 (estimated)
- Study start3 Feb 2018
- Primary completionFeb 2020 (estimated)
- Study completionSep 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 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanan Jafar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanan Jafar, University of Jordan
- Investigators
- Abdallah Awidi, MD, Study director, Cell Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972528
- Sponsor's protocol ID
- DFUUJCTC
- Status last verified
- Aug 2019
- First submitted
- 16 Nov 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Defibrinated Platelet Rich Plasma Lysate for the Healing of Chronic Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT02972528
- Acronym / sponsor ID
- DFUUJCTC
- Conditions
- Diabetic Foot Ulcer
- Keywords
- DFU, Diabetic Foot Ulcer, Diabetes, Platelet Rich Plasma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hanan JafarUniversity, hospital or other
- Study start
- 3 Feb 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 23 Nov 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.
Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed with Diabetic Foot Ulcer (DFU).
Detailed description
In this study, allogenic, defibrinated platelet rich plasma lysate will be used as a direct injection into the periphery of diabetic chronic foot ulcers which have not healed using standard of care. Investigators anticipate a significant response in treated individuals measured by the percentage of skin restoration achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Lysate | Active comparator | Biological: Platelet LysatePatients will receive 5ml peri-lesional injections of Platelet Lysate at weekly intervals, for 4 consecutive times (week 0,1,2,3). |
| Platelet Poor Plasma | Placebo comparator | Biological: Platelet Poor PlasmaPatients will receive 5ml peri-lesional injections of Platelet Poor Plasma at weekly intervals, for 4 consecutive times (week 0,1,2,3). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Persons with type 1 or type 2 diabetes between the ages of 18 and 70 with an ulcer of at least 4 weeks duration
- HemoglobinA1C (HbA1c) < 12
- Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces); and wound area (length x width) measurement between 2 cm2 and 20 cm2, inclusive.
- Wounds located under a Charcot deformity had to be free of acute changes and must have under gone appropriate structural consolidation.
- The index ulcer had to be clinically non-infected and full - thickness without exposure of bone, ligaments, or tendons.
Key exclusion criteria (19 listed)
- Patient currently enrolled in another investigational device or drug trial or previously enrolled (within last 30 days) in investigative research of a device or pharmaceutical agent.
- Ulcer decreased ≥50% in area during 7-day screening period.
- Ulcer is due to non-diabetic etiology.
- Patient's blood vessels are non-compressible for ABI testing.
- Evidence of gangrene in ulcer or on any part of the foot.
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 |
|---|---|---|
| Platelet LysateDirect injection of allogenic Platelet Lysate | Biological | Platelet Lysate |
| Platelet Poor PlasmaDirect injection of allogenic Platelet Poor Plasma | Biological | Platelet Poor Plasma |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection
Time frame: 3 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 allogenic Platelet Lysate 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 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Abdallah Awidi, MD study director
Cell Therapy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet Lysate and Platelet Poor Plasma in people with Diabetic Foot Ulcer, run by Hanan Jafar at 1 site in Jordan.
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 11 inclusion and 19 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 Aug 2019. 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 Jordan. 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.
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 Hanan Jafar, PhD (00962798871087, hanan.jafar@gmail.com), or a site near the patient. 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: 3 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 28 Aug 2019.