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

NCT06680856 | Completed Phase 1

• 1 other identifier: RF-2018-12366868
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

allogeneic Platelet Rich Plasma; diabetic foot ulcer; Hyaluronic acid; skin regeneration

Outcome Measures

Primary Outcomes (1)

• wound size measurements of diabetic foot ulcer lesion

  The cumulative rate of wound healing at the end of the 12 week follow-up was determined by computed-aided imaging on standard pictures of the lesion taken at different times

  12 weeks

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  0,1,2,3,4 and 12 weeks

Other Outcomes (1)

• measurement of HLA antigens in PRP treated patient

  0,4,12 weeks

Study Arms (2)

PRP+HA

EXPERIMENTAL

Diabetic foot ulcers were treated with PRP+HA dressing

Combination Product: PRP+HA

HA alone

ACTIVE COMPARATOR

Diabetic foot ulcers were treated with HA dressing alone

Combination Product: HA

Interventions

PRP+HA COMBINATION_PRODUCT

treatment of diabetic foot ulcers with allogeneic PRP+HA

PRP+HA

HA COMBINATION_PRODUCT

treatment of diabetic foot ulcers with HA

HA alone

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• Between the ages of 40 and 90 years
• Diagnosis of diabetes: random glycaemia \>126 mg in more sample or second hour oral Glucose Tolerance Test glycaemia \>200 mg or glycosylated hemoglobin \>6.5 mmol/L
• The cross-sectional area of the index ulcer will be between 25 and 2000 mm2
• Injury-trophic level Grade I, II, Level A and B (according to Texas classification)
• Ankle Brachial Index \>0.5
• The patient's willingness to cooperate with the physician in follow-up
• No previous treatment with platelet derivatives
• Negative serum pregnancy test within 7 days prior to commencement the treatment in premenopausal women.
• Fertile women must use an effective method of contraception during the treatment and for at least 6 months after completion of treatment as directed by their physician.
• Signature of the informed consent form

You may not qualify if:

• Have End-Stage Renal Disease (ESRD-stage 5 of kidney disease), or severe heart failure which may require organ transplantation
• Are breast-feeding.
• Have a previous or current history of malignant neoplastic disease within the past 5 years
• Have neuropsychiatric diseases that may interfere with the patient's ability to collaborate in the study.
• They have any condition that, in the doctor's judgment, could endanger them.

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead
• IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti: collaborator
• Universita degli Studi di Genova: collaborator

Study Sites (2)

IRCCS Ospedale San Martino

Genova, GE, 16132, Italy

Location

Istituto dermatopatico dell'Immacolata

Roma, Italy

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Giovanni Pratesi, MD

  IRCCS Ospedale San Martino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Vascular Surgery

Model Details: * Experimental Group: Platelet Rich Plasma + Hyaluronic Acid (PRP+HA) (Group 1) * Control Group: Hyaluronic acid gel (HA) (Group 2)

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 8, 2024
• Study Start: February 23, 2021
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)