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Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness

Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04065594
Enrollment
44
Registered
2019-08-22
Start date
2017-06-01
Completion date
2019-04-01
Last updated
2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Skin Ulcer, Non-Healing Ulcer of Skin, Ulcer Foot

Keywords

ulcers, platelet rich plasma, ordinary dressing, non-healing

Brief summary

Background Chronic non-healing ulcer is a common problem met in clinical practice and represents a burden to the patients. Chronic ulcer lacks growth factors (GFs) to promote the healing process and is frequently followed by superadded infections. Ordinary technique such as wound debridement and regular dressings cannot provide adequate results as these techniques cannot provide the necessary GFs. Platelet-rich plasma (PRP) helps wound healing by releasing various types of GFs. The aim: to evaluate and compare the efficacy of PRP dressing versus traditional dressings in the treatment of chronic non-healing leg and foot ulcers of different etiology as regard cost of overall treatment and effectiveness (reduction of the size of the ulcer and safety of the technique). Methods This prospective study was performed on inpatients and outpatients in general surgery department, Zagazig university hospital from June 2017 to January 2019. Patients were divided randomly into two groups: group A received PRP dressing (N=22, 50%) and group B received conventional ordinary dressing (N=22, 50%).The mean follow-up period was 3 months after the last dressing. Patients treated with PRP at once-weekly interval for a maximum of 12 dressings while patients with ordinary dressings may need one dressing every other day for a maximum of 12 weeks. The reduction in the size of the ulcers (area and volume) in both groups was assessed using centimeter scale and Digital photographs before and after each session and during follow up period. Keywords: Platelet-rich plasma, ulcers, non-healing, ordinary dressing.

Detailed description

Chronic non-healing ulcer is a common problem met in clinical practice and represents a burden to the patients. Chronic ulcer lacks growth factors (GFs) to promote the healing process and is frequently followed by superadded infections. Ordinary technique such as wound debridement and regular dressings cannot provide adequate results as these techniques cannot provide the necessary GFs. Platelet-rich plasma (PRP) helps wound healing by releasing various types of GFs. The aim: to evaluate and compare the efficacy of PRP dressing versus traditional dressings in the treatment of chronic non-healing leg and foot ulcers of different etiology as regard cost of overall treatment and effectiveness (reduction of the size of the ulcer and safety of the technique). Methods This prospective study was performed on inpatients and outpatients in general surgery department, Zagazig university hospital from June 2017 to January 2019. Patients were divided randomly into two groups: group A received PRP dressing (N=22, 50%) and group B received conventional ordinary dressing (N=22, 50%).The mean follow-up period was 3 months after the last dressing. Patients treated with PRP at once-weekly interval for a maximum of 12 dressings while patients with ordinary dressings may need one dressing every other day for a maximum of 12 weeks. The reduction in the size of the ulcers (area and volume) in both groups was assessed using centimeter scale and Digital photographs before and after each session and during follow up period. Keywords: Platelet-rich plasma, ulcers, non-healing, ordinary dressing.

Interventions

PROCEDUREPRP dressing

PRP dressing gel dressings for treatment of chronic ulcer

PROCEDUREconventional ordinary dressing

conventional ordinary dressing for treatment of chronic ulcer

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-80 years old, * males and non-pregnant females, * hemoglobin (\> 10 gm. /dL), * post-prandial blood sugar ≤ 140 mg% if diabetic, * Wounds free of infection (sterile swab) or necrosis.

Exclusion criteria

* malignant ulcer(by biopsy), * pus discharge/slough, * ulcer with exposed tendons/ligaments/bone, * ischemic ulcer (by duplex U/S), * non-compliant patients , * radiation near to the site of ulcer, * osteomyelitis of underlying bone (x-ray-bone scan) , * steroids therapy , * thrombocytopenia(\< 150,000/dl) * patients unfit or refuse blood donation from himself or from others.

Design outcomes

Primary

MeasureTime frameDescription
change the ulcer size1.8 yearshealing of the ulcer is assessed using centimeter scale before each dressing

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026