Clinical trial NCT03026855: Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
Official title: To Demonstrate the Safety and Efficacy of Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Ulcer
Keywords: Autologous PRP
Non-healing ulcer
Point-of-care
Lead sponsor: TotipotentRX Cell Therapy Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Platelet Rich Plasma (PRP) therapy is an innovative treatment that uses body's own cells to relieve pain and promote accelerated healing of Non-healing Foot Ulcer /Wound. The body's response to any tissue injury is to deliver platelets, which play an instrumental role in the normal healing process by secreting growth factors and attracting stem cells-critical components of the healing cascade.

Any wound or ulcer on skin that has been present for 4-5 weeks duration, without healing is called a non-healing ulcer. Non-healing ulcers include venous, arterial, diabetic, pressure and traumatic ulcers. Cellular therapies using Autologous Platelet Rich Plasma provides new options for wound healing. The efficacy of the treatment has been proven in surgical applications, in the treatment of severe burns and in transplantation of cells and tissues.

Local application of a solution of plasma enriched in platelets derived from the patient's blood intends to trigger the healing process in non-responsive chronic wound, increase the wound repair rate and reduce pain. PRP is a good option for non-healing wounds because it utilizes the body's natural healing processes to jump-start wound healing. Plasma which contains very valuable growth factors is separated from other blood components utilizing a point of care technology based on density gradient centrifugation. The platelet rich plasma is harvested and then activated by a mixture of human thrombin and calcium chloride for initiating the healing cascade followed by PRP injection directly into the ulcer/wound periphery or spread over a wound in the form of a PRP gel.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Wound/ Ulcers Healed
timeFrame: 24 weeks
Secondary outcomes:
measure: Time to Ulcer Healing
timeFrame: 24 weeks
measure: Reduction in Pain using VAS pain score
timeFrame: 24 weeks
measure: Changes in Quality of Life using the SF-36 Questionnaire
timeFrame: 24 weeks
measure: Number of participants with treatment-related Adverse Events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Delhi
country: India
facility: Fortis Escorts Heart Institute and Research Centre
Study officials:
affiliation: Fortis Escorts Heart Institute and Research Centre
name: Dr. Suhail N Bukhari, MBBS, DNB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.