Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers

NCT03026855 | Completed Phase 1

• 1 other identifier: TPRX/PRP/NHU/141005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection in combination with topical application of PRP gel in treating chronic or non-healing ulcers on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's bedside.

Conditions

Chronic Ulcer

Keywords

Autologous PRP; Non-healing ulcer; Point-of-care

Outcome Measures

Primary Outcomes (1)

• Number of Wound/ Ulcers Healed

  The number of wound/ ulcers healed will be assessed by visual inspection of reduction in wound size at 24 weeks post PRP therapy

  24 weeks

Secondary Outcomes (4)

• Time to Ulcer Healing

  24 weeks

• Reduction in Pain using VAS pain score

  24 weeks

• Changes in Quality of Life using the SF-36 Questionnaire

  24 weeks

• Number of participants with treatment-related Adverse Events

  24 weeks

Study Arms (1)

Autologous PRP Gel and PRP Injection

EXPERIMENTAL

Autologous PRP will be prepared using an advanced rapid point-of-care technology, the Res-Q™ 60 PRP system at the patient's bed side. The Activator solution for PRP gel will be prepared by combining human thrombin (500 IU/ml) with 1% Calcium Chloride.

Biological: Autologous PRP Gel and PRP Injection

Interventions

Autologous PRP Gel and PRP Injection BIOLOGICAL

Autologous PRP prepared using the Res-Q™ 60 PRP system from patient's whole blood, will be injected subcutaneously around the periphery of the wound/ulcer. Based on the wound size and area, autologous platelet gel obtained by spraying simultaneously equal volumes of PRP and activator solution (thrombin with calcium chloride) will be applied topically over the ulcer or wound. Single dose of PRP injections and application of PRP gel will be administered, only on the day of treatment.

Autologous PRP Gel and PRP Injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female 18 to 85 years of age
• Chronic or Non-healing ulcer of any etiology (venous, pressure, arterial or diabetic foot ulcer) which is at least 4 weeks old
• Index foot ulcer located on the plantar, medial or lateral aspect of the foot (including all toe surfaces)
• Wound area (length x width) measurement must be between 0.5 cm\^2 and 10 cm\^2, inclusive
• If more than one non-healing ulcers is present, the largest wound will be selected
• Index ulcer must be clinically non-infected
• Full-thickness ulcer without exposure of bone, muscle, ligament or tendon
• Written informed consent must be obtained from either the patient or the patients legally acceptable representative prior to enrollment

You may not qualify if:

• Patients with known sensitivity to components of the PRP kit (calcium chloride, thrombin, acid citrate dextrose solution A (ACD-A))
• Smokers and individuals with systemic disease or history of anticoagulant, immuno-suppressive or antibiotic therapy in the last 3 months
• Platelet count \< 105 x 10\^3/ uL (according to CBC)
• Hemoglobin level \< 10 g/dL (according to CBC)
• Wound is clinically infected
• Presence of platelet dysfunction syndrome or critical thrombocytopenia
• Bleeding disorders, collagen vascular disease or severe cardiovascular disorder
• Any malignancy other than non-melanoma skin cancer
• Patient is currently receiving or has received radiation or chemotherapy within 3 months prior to treatment
• If female, patient is pregnant, nursing or plans to become pregnant during the duration of the study
• Subject has inadequate venous access for blood draw required for PRP preparation
• Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
• Subject is on dialysis or has uncontrolled sugar levels

Sponsors & Collaborators

• TotipotentRX Cell Therapy Pvt. Ltd.: lead

Study Sites (1)

Fortis Escorts Heart Institute and Research Centre

Delhi, 110025, India

Location

Related Publications (1)

• Suthar M, Gupta S, Bukhari S, Ponemone V. Treatment of chronic non-healing ulcers using autologous platelet rich plasma: a case series. J Biomed Sci. 2017 Feb 27;24(1):16. doi: 10.1186/s12929-017-0324-1.

  PMID: 28241824 DERIVED

Study Officials

• Dr. Suhail N Bukhari, MBBS, DNB

  Fortis Escorts Heart Institute and Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 20, 2017
• Study Start: June 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)