Diabetic Foot UlcersPhase 2/3NCT04315909
The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers
A Phase 2/3 study testing PRP-Fibrin Glue and Vitamin E and C in people with Diabetic Foot Ulcers and Diabetic Wound, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcers, Diabetic Wound
- What is being tested?
- PRP-Fibrin Glue and Vitamin E and C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIran
- Study dates
- 28 Aug 2019to 23 Jun 2020
- Phase
- Phase 2/3
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DFU is classified as Wagner 1 -2 on the Wagner classification system.
- Persons with type 1 or type 2 diabetes with a non-healing ulcer of at least 4 weeks duration.
- If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1- 2.
- The index ulcer had to be clinically non-infected.
- Ankle Brachial Index (ABI) greater than or equal to 0.7.
- HemoglobinA1C (HbA1c) < 12
Show all 11Show fewer
- Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces).
- Wound area (length x width) measurement between 2 cm2 and 20 cm2.
- Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents.
- No smoking, alcohol or drug addiction.
- Approved, informed, signed consent.
Who cannot join
- Previous consumption of vitamin E and C supplements.
- Index ulcer has exposed tendons, ligaments, muscle, or bone.
- Confirmed presence of osteomyelitis, or if osteomyelitis is suspected.
- Patients with renal deficiency, hepatic failure, has known immune insufficiency and cancer.
- Subject is pregnant or plans to become pregnant during the duration of the trial.
- Patient's blood vessels are non-compressible for ABI testing.
- Patient is known to have a psychological, developmental, physical, emotional disorders.
- Received systemic corticosteroids or immunosuppressive agents.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Alavi Hospital
Mashhad, Razavi Khorasan Province, 9137913316
Mohammad-Hadi Saeed Modaghegh, M.D, ModagheghMH@mums.ac.ir
About this study
Official title: A Randomized, Double-Blind, Parallel-group, Clinical Trial to Evaluate the Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers
The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing.
- Conditions
- Diabetic Foot Ulcers, Diabetic Wound
- Being tested
- PRP-Fibrin Glue, Vitamin E and C, Placebo
- Keywords
- Platelet-Rich Plasma-Fibrin Glue, DFU, Vitamin E, Vitamin C, non-healing Diabetic Foot Ulcers
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP-Fibrin GlueDrug
Also called Platelet-Rich Plasma-Fibrin Glue
Platelet-Rich Plasma-Fibrin Glue
Vitamin E and CDietary supplement
Vitamin E and vitamin C
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus vitamin supplements (E (200 IU/ 2day) and C (250 mg/ 2day) ) for 8 weeks. Receives: Drug: PRP-Fibrin Glue; Dietary Supplement: Vitamin E and C |
| Control group | Experimental | Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks. Receives: Drug: PRP-Fibrin Glue; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate of the ulcer
Examination by a vascular surgery physician and documentation
Measured: 2 months
Wound Size
Wound size will be measured with ruler for length, width as well as with digital imaging. Wound size will be assessed in digital images taken of the wound.
Measured: 2 months
Secondary outcomes (11)
Serum ESR at baseline and after the intervention
Erythrocyte Sedimentation Rate
Measured: 2 months
Serum hs-CRP at baseline and after the intervention
high-sensitivity C-Reactive Protein
Measured: 2 months
FBS at baseline and after the intervention
Fasting blood sugar
Measured: 2 months
HbA1c at baseline and after the intervention
Glycated hemoglobin
Measured: 2 months
Lipid Profile at baseline and after the intervention
Serum Triglyceride, Cholesterol, HDL, LDL, VLDL
Measured: 2 months
Serum Urea at baseline and after the intervention
In a quantitative laboratory method
Measured: 2 months
Serum Creatinine at baseline and after the intervention
In a quantitative laboratory method
Measured: 2 months
Serum total bilirubin at baseline and after the intervention
In a quantitative laboratory method
Measured: 2 months
Serum Uric acid at baseline and after the intervention
In a quantitative laboratory method
Measured: 2 months
Serum Homocysteine at baseline and after the intervention
In a quantitative laboratory method
Measured: 2 months
Pro-Oxidant Antioxidant Balance at baseline and after the intervention
The PAB assay is a test to determine the oxidants and antioxidants simultaneously in one single test.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start28 Aug 2019
- Primary completion23 Jun 2020 (estimated)
- Study completion23 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daryoush Hamidi Alamdari, Mashhad University of Medical Sciences
- Investigators
- Daryoush Hamidi Alamdari, Ph.D, Principal investigator, Mashhad University of Medical Sciences, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315909
- Sponsor's protocol ID
- IR.MUMS.REC.1398.125
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data related to the project after unidentifiable of people will be shared.
Publications
Yarahmadi A, Saeed Modaghegh MH, Mostafavi-Pour Z, Azarpira N, Mousavian A, Bonakdaran S, Jarahi L, Samadi A, Peimani M, Hamidi Alamdari D. The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: a randomized, double-blind, parallel-group, clinical trial. Expert Opin Biol Ther. 2021 May;21(5):687-696. doi: 10.1080/14712598.2021.1897100. Epub 2021 Apr 13.
PubMed 33646060
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-group, Clinical Trial to Evaluate the Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04315909
- Acronym / sponsor ID
- IR.MUMS.REC.1398.125
- Conditions
- Diabetic Foot Ulcers, Diabetic Wound
- Keywords
- Platelet-Rich Plasma-Fibrin Glue, DFU, Vitamin E, Vitamin C, non-healing Diabetic Foot Ulcers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 23 Jun 2020 (estimated)
- Study completion
- 23 Jun 2020 (estimated)
- First posted
- 20 Mar 2020 (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.
The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: PRP-Fibrin Glue, Dietary Supplement: Vitamin E and CPatients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus vitamin supplements (E (200 IU/ 2day) and C (250 mg/ 2day) ) for 8 weeks. |
| Control group | Experimental | Drug: PRP-Fibrin Glue, Other: PlaceboPatients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- DFU is classified as Wagner 1 -2 on the Wagner classification system.
- Persons with type 1 or type 2 diabetes with a non-healing ulcer of at least 4 weeks duration.
- If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1- 2.
- The index ulcer had to be clinically non-infected.
- Ankle Brachial Index (ABI) greater than or equal to 0.7.
Key exclusion criteria (8 listed)
- Previous consumption of vitamin E and C supplements.
- Index ulcer has exposed tendons, ligaments, muscle, or bone.
- Confirmed presence of osteomyelitis, or if osteomyelitis is suspected.
- Patients with renal deficiency, hepatic failure, has known immune insufficiency and cancer.
- Subject is pregnant or plans to become pregnant during the duration of the trial.
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 |
|---|---|---|
| PRP-Fibrin GlueAlso: Platelet-Rich Plasma-Fibrin GluePlatelet-Rich Plasma-Fibrin Glue | Drug | Control group, Intervention group |
| Vitamin E and CVitamin E and vitamin C | Dietary supplement | Intervention group |
| PlaceboPlacebo | Other | Control group |
Primary outcome
Healing rate of the ulcer
Time frame: 2 months
Examination by a vascular surgery physician and documentation
Wound Size
Time frame: 2 months
Wound size will be measured with ruler for length, width as well as with digital imaging. Wound size will be assessed in digital images taken of the wound.
11 secondary outcomes
Serum ESR at baseline and after the intervention
Time frame: 2 months
Serum hs-CRP at baseline and after the intervention
Time frame: 2 months
FBS at baseline and after the intervention
Time frame: 2 months
HbA1c at baseline and after the intervention
Time frame: 2 months
Lipid Profile at baseline and after the intervention
Time frame: 2 months
Serum Urea at baseline and after the intervention
Time frame: 2 months
Serum Creatinine at baseline and after the intervention
Time frame: 2 months
Serum total bilirubin at baseline and after the intervention
Time frame: 2 months
Serum Uric acid at baseline and after the intervention
Time frame: 2 months
Serum Homocysteine at baseline and after the intervention
Time frame: 2 months
Pro-Oxidant Antioxidant Balance at baseline and after the intervention
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Derived from this study: PubMed 33646060Yarahmadi A, Saeed Modaghegh MH, Mostafavi-Pour Z, Azarpira N, Mousavian A, Bonakdaran S, Jarahi L, Samadi A, Peimani M, Hamidi Alamdari D. The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: a randomized, double-blind, parallel-group, clinical trial. Expert Opin Biol Ther. 2021 May;21(5):687-696. doi: 10.1080/14712598.2021.1897100. Epub 2021 Apr 13.
- Individual participant dataSharing planned: Yes. All data related to the project after unidentifiable of people will be shared.
Related trials for Diabetic Foot Ulcers
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.
Daryoush Hamidi Alamdari, Ph.D principal investigator
Mashhad University of Medical Sciences, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PRP-Fibrin Glue and Vitamin E and C in people with Diabetic Foot Ulcers and Diabetic Wound, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 8 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 20 Mar 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 Iran. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Daryoush Hamidi Alamdari, Ph.D (+98 51 3882 8574, hamidiad@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate of the ulcer (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315909, which also lists 1 linked publication.
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 20 Mar 2020.