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Allogeneic Platelet Rich Plasma (PRP) to Treat Diabetic Foot Ulcers

NCT06680856 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-11-08

No results posted yet for this study

Summary

Chronic skin ulcers pose a major health burden because of population aging and increased prevalence of chronic diseases such as diabetes. Standard therapy, such as ulcer debriding and physical treatments, is in most cases palliative. Autologous Platelet Rich Plasma (PRP) as enhancer of healing was proposed as a real innovation in the field. However, conflicting results were obtained by different groups, because of the different production and clinical protocols and inter-individual variability in the patient's blood.

A multi center double-blind, randomized clinical trial was conducted to test an allogeneic platelet-derived product obtained from large pools of blood donations for the treatment of diabetic foot ulcers in association with Hyaluronic Acid (HA) dressing as compared to Hyaluronic Acid alone. Being prepared in batches, the product undergoes rigorous Quality Control analysis before use. An allogeneic PRP product would represent a substantial improvement in the treatment of skin ulcers.

Conditions

  • Diabetic Foot Ulcer
  • Skin Lesions
  • Allogeneic
  • PRP

Interventions

COMBINATION_PRODUCT

PRP+HA

treatment of diabetic foot ulcers with allogeneic PRP+HA

COMBINATION_PRODUCT

HA

treatment of diabetic foot ulcers with HA

Sponsors & Collaborators

  • IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti

    collaborator OTHER

  • Universita degli Studi di Genova

    collaborator OTHER

  • Ospedale Policlinico San Martino

    lead OTHER

Principal Investigators

  • Giovanni Pratesi, MD · IRCCS Ospedale San Martino

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2024-10-17
Completion
2024-10-17

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680856 on ClinicalTrials.gov