NCT03250403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

August 8, 2017

Last Update Submit

July 12, 2018

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

  • Numbness

    modified Toronto Clinical Neuropathy Score

    6 months

  • pain

    VAS 0-10 scale

    6 months

Secondary Outcomes (1)

  • Conduction velocity

    6 months

Study Arms (2)

PRP injection

EXPERIMENTAL
Drug: PRP injectionOther: traditional medical treatment

medical treatment

ACTIVE COMPARATOR
Other: traditional medical treatment

Interventions

PRP injectionDRUG

peri-neural injection of platelet rich plasma

PRP injection
traditional medical treatmentOTHER

traditional medical treatment

PRP injectionmedical treatment

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University

Asyut, 7111, Egypt

Location

Study Officials

  • Abdelraheem M Alawaamy, Dr

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prenciple investigator

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 15, 2017

Study Start

April 1, 2017

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

July 13, 2018

Record last verified: 2018-07

Locations

EG(1)