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Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy

Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy: Double Blinded Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03250403
Enrollment
60
Registered
2017-08-15
Start date
2017-04-01
Completion date
2017-10-01
Last updated
2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathy

Brief summary

To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment.

Detailed description

Background: Neuropathy is a common complication of diabetes mellitus (DM) with a wide clinical spectrum that encompasses generalized to focal and multifocal forms not only leads to an impaired quality of life, but also to an increased morbidity and mortality . Till now there is no available effective therapy for the treatment of diabetic peripheral neuropathy (DPN). Autologous platelet-rich plasma is easy and cost-effective method as it provides necessary growth factors that promote wound healing/growth, angiogenesis, and axon regeneration . Objective: To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment. Method : Prospective double blinded randomized controlled trial was conducted . All included patients had type 2 DM selected from Endocrinology unit Department of Internal medicine, Assuit university Hospital, Egypt . DPN of at least 5 years duration of symptoms . Patients with other causes of neuropathy like hereditary neuropathies , entrapment neuropathies ,connective tissue diseases , vertebral diseases ,thyroid disorders and end organ failure were excluded . Neuropathy was assessed by the modified Toronto Clinical Neuropathy Score (mTCNS) 2001 (3) , Baseline pain and nerve conduction studies were done. Then they were double blindly divided into two groups, Group I underwent PRP preineural injection under ultrasound guidance plus medical treatment . Group װreceived medical treatment only( control group) . Blood glucose was strictly controlled in both groups . Patients were followed every month for 3 months by mTCNS and by nerve conduction studies. Results were expressed as means ± standard deviation or frequencies. Independent Student's t test was done for comparison between groups

Interventions

DRUGPRP injection

peri-neural injection of platelet rich plasma

OTHERtraditional medical treatment

traditional medical treatment

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Diabetic peripheral neuropathy of at least 5 years duration of symptoms

Exclusion criteria

* hereditary neuropathies , entrapment neuropathies , connective tissue diseases , vertebral diseases , thyroid disorders and end organ failure

Design outcomes

Primary

MeasureTime frameDescription
Numbness6 monthsmodified Toronto Clinical Neuropathy Score
pain6 monthsVAS 0-10 scale

Secondary

MeasureTime frameDescription
Conduction velocity6 monthsMeter/second

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026