Clinical trial NCT05974982: Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers
Official title: Comparison of the Outcome of Treatment With Autologous Platelet Rich Plasma Versus Conventional Therapy for Patients Presenting With Chronic Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Venous Leg Ulcer
Lead sponsor: Jinnah Postgraduate Medical Centre
Sponsor class: OTHER_GOV
First posted: 2023-08-03
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of PRP has dramatically increased in the fields of orthopedics, spine surgery, reconstructive plastic surgery, oral and maxillofacial surgery, and dermatological indications. Nonetheless, its use in the treatment of wounds is not as widespread as in other fields. In this experimental study, the treatment outcome of autologous PRP was assessed in comparison to conventional therapy among patients with chronic venous leg ulcers.

Detailed description: Venous ulcers are the most common form of leg ulcers which have a significant impact on quality of life and work productivity. In addition, the costs associated with the long-term care of these chronic wounds are substantial. Conventional therapies such as dressings, surgical debridement, compression bandage, and even skin grafting cannot provide satisfactory healing since these treatments are not able to provide necessary growth factors that can modulate healing processes. Autologous platelet-rich plasma (PRP) is a safe, simple, affordable, and less expensive procedure in the treatment of chronic ulcers with reportedly good results. Since it is an autologous method, it is biocompatible and safe. Data from this would help in establishing it as a treatment of choice, thereby leading to a reduction in cost and benefiting the patient both financially and psychologically.

PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e., five times more than normal platelet counts. PRP enhances wound healing by promoting the healing process by seven growth factors present in it. They are platelet-derived growth factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, and transforming growth factor. These growth factors are important in modulating mesenchymal cell recruitment, proliferation, and extra-cellular matrix synthesis during the healing process.

Eligibility criteria: Inclusion Criteria:

* Patients aged 30-80 years of any gender presented with chronic venous leg ulcers

Exclusion Criteria:

* Patients with history of peripheral arterial disease.
* Patients with history of acute venous thromboembolism.
* Patients with platelet count less than 150000.
* Patients with history of bleeding disorders.
* Patients with history of osteoporosis.
* Patients with history of peripheral neuropathy.
* Pregnant patients assessed by history and confirmed by dating scan.
* Patients with history of congestive cardiac failure, chronic liver disease, asthma, COPD, or stroke.

Primary outcomes:
measure: Complete healing
timeFrame: 9 months
measure: Length of ulcer
timeFrame: 9 months
measure: Width of ulcer
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jinnah Post graduate Medical centre
state: Sindh
Study officials:
affiliation: Jinnah Post Graduate Medical Centre
name: Rabia Ghafoor
role: STUDY_DIRECTOR
References: