Diabetic NeuropathiesNCT03601494
Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain
A study testing perineural injection of platelet-rich plasma and medical in people with Diabetic Neuropathies and Chronic Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Peripheral neuropathy is very common in diabetes mellitus (DM). Till now there is no available effective therapy for this pathology. Objective: To evaluate the clinical effect of perineural platelet-rich plasma (PRP) injection as a treatment of diabetic peripheral neuropathy (DPN). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetic Neuropathies, Chronic Pain
- What is being tested?
- perineural injection of platelet-rich plasma and medical
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2017to 18 Feb 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- type II diabetes mellitus
- diabetic peripheral neuropathy
- six months duration of symptoms,
Who cannot join
- other causes of neuropathy
- patient refusal
- ulcers or amputations
- peripheral vascular diseases
- vertebral spine disease
- connective tissue disease
Show all 10Show fewer
- platelet dysfunction syndrome
- critical thrombocytopenia
- local infection
- coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perineural Platelet Rich Plasma for Pain and Disability Management in Diabetic Peripheral Neuropathy
Peripheral neuropathy is very common in diabetes mellitus (DM). Till now there is no available effective therapy for this pathology. Objective: To evaluate the clinical effect of perineural platelet-rich plasma (PRP) injection as a treatment of diabetic peripheral neuropathy (DPN).
Read the detailed description
Diabetic Peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM). Among several complications that contribute to reduce patient's quality of life and life expectancy diabetic neuropathy (DN) generalized or focal leads to an impaired life quality.
The clinical symptoms of DPN range from pain and burning sensations, more at rest or at night; to hypoesthesia or paresthesia, and or numbness.
Different types of peripheral neuropathy are observed in diabetes, axonal or demyelination or both can be present, involves myelinated and un-myelinated, large and small fibers. Nerve conduction studies can detect these changes. Till now, there is no effective therapy for the treatment of DPN.
Since 1950 Platelet-rich plasma (PRP) has been used in dermatology and oral maxillofacial surgery, but its role as an effective alternative treatment in many other clinical applications has been increased over the last years.
Platelets contain more than 1100 proteins, include enzymes, enzyme inhibitors, growth factors, immune messengers, and other bioactive compounds which play a role in tissue repair and wound healing.
Autologous platelet-rich plasma found to promote axon regeneration in studies involving animal models. Platelet derived angiogenesis factors are capable of stimulating new capillary growth by inducing migration of endothelial cells. It was suggested that this was the mechanism by which platelet factors influence the process of angiogenesis and revascularization.
- Conditions
- Diabetic Neuropathies, Chronic Pain
- Being tested
- perineural injection of platelet-rich plasma, medical
- Keywords
- Diabetic Neuropathies, Chronic pain
- Medical subject headings
- Diabetic Neuropathies, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineural injection of platelet-rich plasmaOther
Sonographic guided injection was done under complete sterile conditions including skin sterilization, ultrasound probe covered with sterile pad, and a sterile gel. The needle was introduced from the lateral side toward midline using the in-plane approach to target the desired nerve, each nerve was injected by a single dose of 1.5 cc of PRP. Free hand one-man technique was used by the physician who simultaneously managed the ultrasound device by holding the syringe with one hand while scanning the nerve by moving the probe with the other hand. With continuous imaging of the tip of the needle, the syringe was put around the nerve and platelet-rich plasma was injected in the peri-neural tissue.
medicalDrug
vitamin B complex, α lipoic acid, selective serotonin reuptake inhibitor (SSRI)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment. Receives: Other: perineural injection of platelet-rich plasma; Drug: medical |
| Control | Placebo comparator | medical treatment only Receives: Drug: medical |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale of pain
it will be measured by visual analog scale
Measured: 6 months
Secondary outcomes (1)
Nerve conduction velocity
changes in nerve conduction velocities in meters/ seconds
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Feb 2017
- Primary completion22 Nov 2017
- Study completion18 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601494
- Sponsor's protocol ID
- IRB00009919
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Platelet Rich Plasma for Pain and Disability Management in Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03601494
- Acronym / sponsor ID
- IRB00009919
- Conditions
- Diabetic Neuropathies, Chronic Pain
- Keywords
- Diabetic Neuropathies, Chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 18 Feb 2018 (actual)
- First posted
- 26 Jul 2018 (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.
Peripheral neuropathy is very common in diabetes mellitus (DM). Till now there is no available effective therapy for this pathology. Objective: To evaluate the clinical effect of perineural platelet-rich plasma (PRP) injection as a treatment of diabetic peripheral neuropathy (DPN).
Detailed description
Diabetic Peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM). Among several complications that contribute to reduce patient's quality of life and life expectancy diabetic neuropathy (DN) generalized or focal leads to an impaired life quality.
The clinical symptoms of DPN range from pain and burning sensations, more at rest or at night; to hypoesthesia or paresthesia, and or numbness.
Different types of peripheral neuropathy are observed in diabetes, axonal or demyelination or both can be present, involves myelinated and un-myelinated, large and small fibers. Nerve conduction studies can detect these changes. Till now, there is no effective therapy for the treatment of DPN.
Since 1950 Platelet-rich plasma (PRP) has been used in dermatology and oral maxillofacial surgery, but its role as an effective alternative treatment in many other clinical applications has been increased over the last years.
Platelets contain more than 1100 proteins, include enzymes, enzyme inhibitors, growth factors, immune messengers, and other bioactive compounds which play a role in tissue repair and wound healing.
Autologous platelet-rich plasma found to promote axon regeneration in studies involving animal models. Platelet derived angiogenesis factors are capable of stimulating new capillary growth by inducing migration of endothelial cells. It was suggested that this was the mechanism by which platelet factors influence the process of angiogenesis and revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: perineural injection of platelet-rich plasma, Drug: medicalperi-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment. |
| Control | Placebo comparator | Drug: medicalmedical treatment only |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- type II diabetes mellitus
- diabetic peripheral neuropathy
- six months duration of symptoms,
Key exclusion criteria (10 listed)
- other causes of neuropathy
- patient refusal
- ulcers or amputations
- peripheral vascular diseases
- vertebral spine disease
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 |
|---|---|---|
| perineural injection of platelet-rich plasmaSonographic guided injection was done under complete sterile conditions including skin sterilization, ultrasound probe covered with sterile pad, and a sterile gel. The needle was introduced from the lateral side toward midline using the in-plane approach to target the desired nerve, each nerve was injected by a single dose of 1.5 cc of PRP. Free hand one-man technique was used by the physician who simultaneously managed the ultrasound device by holding the syringe with one hand while scanning the nerve by moving the probe with the other hand. With continuous imaging of the tip of the needle, the syringe was put around the nerve and platelet-rich plasma was injected in the peri-neural tissue. | Other | Intervention |
| medicalvitamin B complex, α lipoic acid, selective serotonin reuptake inhibitor (SSRI) | Drug | Control, Intervention |
Primary outcome
visual analog scale of pain
Time frame: 6 months
it will be measured by visual analog scale
1 secondary outcome
Nerve conduction velocity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Diabetic Neuropathies
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
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
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 study testing perineural injection of platelet-rich plasma and medical in people with Diabetic Neuropathies and Chronic Pain, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 26 Jul 2018. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
visual analog scale of pain (time frame: 6 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 26 Jul 2018.