Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain

Assiut University

Status: Completed

Conditions: Chronic Pain; Diabetic Neuropathies

Treatments: Drug: medical; Other: perineural injection of platelet-rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03601494

IRB00009919

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type II diabetes mellitus
• diabetic peripheral neuropathy
• six months duration of symptoms,

Exclusion criteria

• other causes of neuropathy
• patient refusal
• ulcers or amputations
• peripheral vascular diseases
• vertebral spine disease
• connective tissue disease
• platelet dysfunction syndrome
• critical thrombocytopenia
• local infection
• coagulopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment.

Treatment:

Drug: medical

Other: perineural injection of platelet-rich plasma

Control

Placebo Comparator group

Description:

medical treatment only

Treatment:

Drug: medical