Diabetic Foot UlcerPhase 1EVDFUUJCTCNCT06825884
Use of Extracellular Vesicles (EV) for Diabetic Foot Ulcers
A Phase 1 study testing Extracellular micro vesicles (EV) in people with Diabetic Foot Ulcer, run by University of Jordan at 1 site in Jordan.
Trial summary
Diabetes Mellitus is a common chronic medical condition that requires complex care strategies. Treatment includes methods to reduce glycemic burden and maintain glycemic control in the patient to prevent symptoms of hyperglycemia and reduce microvascular complications. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Extracellular micro vesicles (EV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJordan
- Study dates
- 1 Dec 2024to 31 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons with type 2 diabetes between the ages of 30 and 75 with an ulcer of at least 6 weeks' duration. 2. Hemoglobin A1C< 11. 3. 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 1 cm 2 and 60 cm 4. Wounds located under a Charcot deformity should be free of acute changes and must have undergone appropriate structural consolidation. 5. The index ulcer should be clinically non-infected and full-thickness without exposure of bone. 6. The protocol requires that post debridement; the ulcer would be free of necrotic debris, foreign bodies or sinus tracts. 7. Non- invasive vascular testing ankle brachial pressure index (ABPI) < 0.80. 8. Physical examination (including a Semmes-Weinstein monofilament test for neuropathy using the 5.07/10 g monofilament to test the plantar aspects of the great toe, third, and fifth metatarsal heads. 9. Negative for infectious panel (HIV, HBV, HCV, and VDRL). 10. Approved signed informed consent. 11. Coding and Randomization.
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 (up to) 25% 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.
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- Patient is currently receiving or has received radiation or chemotherapy within 3 months of treatment.
- Patient has received growth factor therapy within 7 days of treatment.
- Screening hemoglobin \<10.0 mg/dL.
- Screening platelet count \< 100 x 10 9 /L.
- Patient is undergoing renal dialysis, has known immune insufficiency, known abnormal platelet activation disorders, eating/ nutritional, hematologic, collagen vascular disease, rheumatic disease, or bleeding disorders.
- History of peripheral vascular repair within the 30 days.
- Patient has known or suspected osteomyelitis.
- Surgical correction (other than debridement) required for ulcer to heal.
- Index ulcer has exposed 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.
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes Mellitus is a common chronic medical condition that requires complex care strategies. Treatment includes methods to reduce glycemic burden and maintain glycemic control in the patient to prevent symptoms of hyperglycemia and reduce microvascular complications. In the case of patients with diabetes mellitus, wound healing, skin re- epithelization and skin integrity restoration are compromised, leading to chronic cutaneous ulcers such as diabetic foot ulcers. As much as 15% of all diabetic patients manifest diabetic foot ulcers. Moreover, 84% of all diabetes related lower leg amputations are anticipated to the result of diabetic foot ulcers. Compromised chronic cutaneous ulcer healing may result from cytokines, growth factor deficits, and insufficient angiogenesis process.
Read the detailed description
Diabetes Mellitus is a common chronic medical condition that requires complex care strategies. Treatment includes methods to reduce glycemic burden and maintain glycemic control in the patient to prevent symptoms of hyperglycemia and reduce microvascular complications. In the case of patients with diabetes mellitus, wound healing, skin re- epithelization and skin integrity restoration are compromised, leading to chronic cutaneous ulcers such as diabetic foot ulcers. As much as 15% of all diabetic patients manifest diabetic foot ulcers. Moreover, 84% of all diabetes-related lower leg amputations are anticipated to be the result of diabetic foot ulcers. Compromised chronic cutaneous ulcer healing may be ascribed to cytokines, growth factor deficits, and insufficient angiogenesis process.
Wound healing is a process that begins as a reaction to skin injury, re-epithelization is a crucial phase of the wound healing, and it is impelled by keratinocytes migration and proliferation. Cell migration and proliferation are initiated and regulated by growth factors and cytokines that are released from the wounded epithelium. Restoration of skin integrity in the case of chronic cutaneous ulcers in patients with diabetes mellitus is compromised. Autologous human platelet granules, such as human platelet lysate (hPL) and extracellular micro vesicles (EV), represent a promising source of bioactive substances and have shown to be effective both in vitro and in vivo in wound healing studies. Prior studies supported the use of platelet rich plasma and extracellular micro vesicles in healing chronic lower extremity wounds and the treatment of diabetic foot ulcers.
The investigators are proposing this work for the use of bioactive substance:
Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care. This is a clinical study in chronic DFU stage A2 and A3 as per the university of Texas DFU classification (Appendix I), corresponding to Wegner classification III; IV.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Extracellular micro vesicles (EV)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracellular micro vesicles (EV)Biological
Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Extracellular vesicles (EV) | Experimental | * Patients will receive 5 ml perilesional injections as treatment weekly interval.
* Post injection dressing will be with exofiber and bandaging.
* Off-loading will apply when required.
* Quantitative ulcer healing will be calculated according the surface area of the remaining ulcer at week 10 and12.
* Standard of care will be given throughout the whole study period from week 1 through week 12. Receives: Biological: Extracellular micro vesicles (EV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the short-term speed and effectiveness of extracellular micro vesicles (EV) on the healing of diabetic foot ulceration. And to prove that extracellular micro vesicles (EV) will significantly shorten the required timeto heal DFU.
After measuring the wound area surface
- the investigators will consider that the wound is full-healed when its surface area is healed (100%)
- the investigators will consider that the wound is partial-healed when its surface area is healed (50- 100%)
- the investigators will consider that the wound is minimal-healed when its surface area is healed (25- 50%)
- the investigators will consider that the wound is non-healed when its surface area is <25%
Measured: follow-up duration is 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- Abdalla Awidi Abbadi, MD
- Responsible party
- Principal investigator, Hanan Jafar, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825884
- Sponsor's protocol ID
- EVDFUUJCTC
- Other IDs
- University of Jordan
- Acronym
- EVDFUUJCTC
- Status last verified
- Apr 2025
- First submitted
- 23 Jan 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Extracellular Vesicles (EV) for Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06825884
- Acronym / sponsor ID
- EVDFUUJCTC / EVDFUUJCTC
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- Abdalla Awidi Abbadi, MD
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Feb 2025 (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 Mellitus is a common chronic medical condition that requires complex care strategies. Treatment includes methods to reduce glycemic burden and maintain glycemic control in the patient to prevent symptoms of hyperglycemia and reduce microvascular complications. In the case of patients with diabetes mellitus, wound healing, skin re- epithelization and skin integrity restoration are compromised, leading to chronic cutaneous ulcers such as diabetic foot ulcers. As much as 15% of all diabetic patients manifest diabetic foot ulcers. Moreover, 84% of all diabetes related lower leg amputations are anticipated to the result of diabetic foot ulcers. Compromised chronic cutaneous ulcer healing may result from cytokines, growth factor deficits, and insufficient angiogenesis process.
Detailed description
Diabetes Mellitus is a common chronic medical condition that requires complex care strategies. Treatment includes methods to reduce glycemic burden and maintain glycemic control in the patient to prevent symptoms of hyperglycemia and reduce microvascular complications. In the case of patients with diabetes mellitus, wound healing, skin re- epithelization and skin integrity restoration are compromised, leading to chronic cutaneous ulcers such as diabetic foot ulcers. As much as 15% of all diabetic patients manifest diabetic foot ulcers. Moreover, 84% of all diabetes-related lower leg amputations are anticipated to be the result of diabetic foot ulcers. Compromised chronic cutaneous ulcer healing may be ascribed to cytokines, growth factor deficits, and insufficient angiogenesis process.
Wound healing is a process that begins as a reaction to skin injury, re-epithelization is a crucial phase of the wound healing, and it is impelled by keratinocytes migration and proliferation. Cell migration and proliferation are initiated and regulated by growth factors and cytokines that are released from the wounded epithelium. Restoration of skin integrity in the case of chronic cutaneous ulcers in patients with diabetes mellitus is compromised. Autologous human platelet granules, such as human platelet lysate (hPL) and extracellular micro vesicles (EV), represent a promising source of bioactive substances and have shown to be effective both in vitro and in vivo in wound healing studies. Prior studies supported the use of platelet rich plasma and extracellular micro vesicles in healing chronic lower extremity wounds and the treatment of diabetic foot ulcers.
The investigators are proposing this work for the use of bioactive substance:
Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care. This is a clinical study in chronic DFU stage A2 and A3 as per the university of Texas DFU classification (Appendix I), corresponding to Wegner classification III; IV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care.
| Arm | Type | Receives |
|---|---|---|
| Extracellular vesicles (EV) | Experimental | Biological: Extracellular micro vesicles (EV)* Patients will receive 5 ml perilesional injections as treatment weekly interval. * Post injection dressing will be with exofiber and bandaging. * Off-loading will apply when required. * Quantitative ulcer healing will be calculated according the surface area of the remaining ulcer at week 10 and12. * Standard of care will be given throughout the whole study period from week 1 through week 12. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons with type 2 diabetes between the ages of 30 and 75 with an ulcer of at least 6 weeks' duration. 2. Hemoglobin A1C< 11. 3. 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 1 cm 2 and 60 cm 4. Wounds located under a Charcot deformity should be free of acute changes and must have undergone appropriate structural consolidation. 5. The index ulcer should be clinically non-infected and full-thickness without exposure of bone. 6. The protocol requires that post debridement; the ulcer would be free of necrotic debris, foreign bodies or sinus tracts. 7. Non- invasive vascular testing ankle brachial pressure index (ABPI) < 0.80. 8. Physical examination (including a Semmes-Weinstein monofilament test for neuropathy using the 5.07/10 g monofilament to test the plantar aspects of the great toe, third, and fifth metatarsal heads. 9. Negative for infectious panel (HIV, HBV, HCV, and VDRL). 10. Approved signed informed consent. 11. Coding and Randomization.
Key exclusion criteria (17 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 (up to) 25% 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 |
|---|---|---|
| Extracellular micro vesicles (EV)Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care. | Biological | Extracellular vesicles (EV) |
Primary outcome
To determine the short-term speed and effectiveness of extracellular micro vesicles (EV) on the healing of diabetic foot ulceration. And to prove that extracellular micro vesicles (EV) will significantly shorten the required timeto heal DFU.
Time frame: follow-up duration is 12 months
After measuring the wound area surface * the investigators will consider that the wound is full-healed when its surface area is healed (100%) * the investigators will consider that the wound is partial-healed when its surface area is healed (50- 100%) * the investigators will consider that the wound is minimal-healed when its surface area is healed (25- 50%) * the investigators will consider that the wound is non-healed when its surface area is <25%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Extracellular micro vesicles (EV) in people with Diabetic Foot Ulcer, run by University of Jordan 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 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. 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. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
To determine the short-term speed and effectiveness of extracellular micro vesicles (EV) on the healing of diabetic foot ulceration. And to prove that extracellular micro vesicles (EV) will significantly shorten the required timeto heal DFU. (time frame: follow-up duration is 12 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 16 Apr 2025.