Platelet-Rich Plasma for Wound Care in the Medicare Population

Project Summary Title and Description

Platelet-Rich Plasma for Wound Care in the Medicare Population
Objectives. To evaluate the effectiveness of autologous platelet-rich plasma (PRP) in individuals with lower extremity diabetic ulcers, lower extremity venous ulcers, and pressure ulcers. Data sources. MEDLINE, Embase, Cochrane Central Registrar of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, Scopus and various grey literature sources from database inception to June 11, 2020. Review methods. We included randomized controlled trials (RCTs) and comparative observational studies that compared PRP to any other wound care without PRP in adult patients. Pairs of independent reviewers selected and appraised studies. Meta-analysis was conducted when appropriate and the strength of evidence (SOE) was determined based on a priori plan. Results. We included 27 studies (22 randomized, 5 comparative observational studies, total of 1,796 patients). 15 studies enrolled patients with lower extremity diabetic ulcers, 11 enrolled patients with lower extremity venous ulcers, and 2 enrolled patients with pressure ulcers in any location. Followup after intervention ranged from no followup to 11 months. The available studies suffered from important limitations, such as inadequate description of offloading and wound care procedures, wound characteristics, platelet-rich plasma formulation techniques, concentration and volume; inadequate length of followup; and lack of stratification by comorbidities and other patient characteristics including older adults. Compared with management without PRP, PRP therapy increased complete wound closure or healing in lower extremity diabetic ulcers (RR: 1.20; 95% CI: 1.09 to 1.32, moderate SOE), shortened the time to complete wound closure, and reduced wound area and depth (low SOE), although Medicare-eligible older adults were underrepresented in the included studies. No significant changes were found in terms of wound infection, amputation, wound recurrence, or hospitalization. In patients with lower extremity venous ulcers, the SOE was insufficient to estimate an effect on critical outcomes, such as complete wound closure or time to complete wound closure. Similarly, evidence was insufficient to estimate an effect on any outcome in pressure ulcers. There was no statistically significant difference in death, total adverse events or serious adverse events between PRP and management without PRP. Conclusions. Autologous platelet-rich plasma based on moderate SOE increases complete wound closure or healing, and low SOE shortens healing time and reduces wound size in individuals with lower extremity diabetic ulcers. The evidence is insufficient to estimate an effect of autologous platelet-rich plasma on wound healing in individuals with lower extremity venous ulcers or pressure ulcers.
Authors of Report
Methodology description
We developed an analytic framework to guide the process of the systematic review. We followed the established methodologies of systematic reviews as outlined in Agency for Healthcare Research and Quality (AHRQ) Methods Guide for Comparative Effectiveness Reviews. The reporting complies with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements. The study protocol is published on AHRQ website and registered in the international prospective register of systematic reviews (PROSPERO #: CRD42020172817). The full report details our literature search strategy, inclusion and exclusion criteria, data synthesis, assessments of risk of bias, and strength of evidence (SOE). We assigned SOE rating as high, moderate, low, or ‘insufficient evidence to estimate an effect’. High was rated when we were very confident that the estimate of effect lies close to the true effect (the body of evidence has few or no deficiencies and is judged to be stable). Moderate was rated if we were moderately confident that the estimate of effect lies close to the true effect (the body of evidence has some deficiencies and is judged to be likely stable). Low, we had limited confidence that the estimate of effect lies close to the true effect (the body of evidence has major or numerous deficiencies and is likely unstable), and insufficient if we had no evidence, are unable to estimate an effect, or have no confidence in the estimate of effect.
Web address: Data in this report is presented retrospectively. Data can be found in the following links: Characteristic of included studies: Inclusion and exclusion criteria: Description of Management without PRPR of the included studies: Risk of Bias: Description of PRPR formulation and application: Wound measurement and assessment methods: Summary findings of included studies: Patient characteristics commonly considered for the initiation and continuation: FDA Cleared Device for autologous PRP Preparation Description of PRP Being Investigated in Ongoing Trials
Funding Source

Key Questions

1. KQ 1. What are the benefits and harms of treatment strategies including PRP alone with or without other wound care treatments compared with other wound care treatments in patients with diabetic, venous and pressure chronic wounds, for patient oriented outcomes such as at least the following: completely closed/healed wounds (skin closure with complete re-epithelialization without drainage or dressing requirements), time to complete wound closure, wound reoccurrence, risk of developing wound infection, amputation, hospitalization (frequency and duration), return to baseline activities and function, reduction of wound size, pain, opioid medication use, exudate and odor, quality of life and adverse effects? KQ 1.a. Describe the risk of bias in the studies examined by chronic wound type and study design. KQ 1.b What are the differences in formulation techniques and components between these preparations? What are the differences in application techniques, frequency of application and “dosage” (amounts applied)? KQ 1.c What are the study characteristics (such as those listed below) in each included investigation for each chronic wound type treated by PRP? i. Comparator (if standard care, describe in detail). ii. Study inclusion/exclusion criteria and patient characteristics of enrollees, including at least age, gender, and general health (e.g., status of HbA1c, diabetes, peripheral vascular disease, obesity, smoking, renal), wound characteristics, and prior and concurrent wound treatments. iii. Wound characteristics of enrollees including at least wound type, wound size/depth/duration/severity, vascular status, infection status and whether there were inter- and intra-rater checks of wound measurements. iv. Basic study design and conduct information including at least method of patient enrollment, care setting, and use of run-in period. v. Definition of wound characteristics: definition of “failure to heal”, and definition of a successfully healed wound (re-epithelialization). vi. Method of applying skin PRP including provider, frequency of application, definition of standard of care, and handling of infections. vii. Measurement and assessment methods including method of assessment(s); frequency and time points for assessment(s) (including long term assessments for durability of heal); and blinding of assessors. KQ 1.d Based on the included studies, what are the patient characteristics commonly considered for the initiation and continuation/discontinuation of PRP in patients with chronic wounds?
2. KQ 2. What types of PRP preparations are currently being marketed in US medical practices (gel, liquid, etc.)?
3. KQ 3. What PRP preparations are currently being investigated in ongoing trials?
4. KQ 4. What best practices in study design could be used to produce high quality evidence on PRP?
5. KQ 5. What are the evidence gaps found in this body of research?

Associated Extraction Forms

Associated Studies (each link opens a new tab)

Platelet-Rich Plasma for the Treatment of Clean Diabetic Foot Ulcers.2017
Autologous platelet-rich plasma in the treatment of venous leg ulcers in primary care: a randomised controlled, pilot study.2018
A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers.2006
Autologous platelet-rich plasma injection enhances healing of chronic venous leg ulcer: A prospective randomised study.2020
Randomized Controlled Trial on Autologous Platelet-Rich Plasma Versus Saline Dressing in Treatment of Non-healing Diabetic Foot Ulcers.2020
Efficacy and safety of the use of platelet-rich plasma to manage venous ulcers.2017
Aurix Gel Is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial.2019
Synergistic action of protease-modulating matrix and autologous growth factors in healing of diabetic foot ulcers. A prospective randomized trial.-- Not Found --
Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.-- Not Found --
Role of plasma growth factor in the healing of chronic ulcers of the lower legs and foot due to ischaemia in diabetic patients.2017
Autologous Platelet-Rich Plasma Reduces Healing Time of Chronic Venous Leg Ulcers: A Prospective Observational Study.2019
Autologous platelet-rich plasma versus conventional therapy for the treatment of chronic venous leg ulcers: A comparative study.2018
Platelet-rich plasma versus platelet-poor plasma in the management of chronic diabetic foot ulcers: a comparative study.2011
A controlled study of the use of autologous platelet gel for the treatment of diabetic foot ulcers.2004
Randomized trial and local biological effect of autologous platelets used as adjuvant therapy for chronic venous leg ulcers.2003
Role of local application of autologous platelet-rich plasma in the management of pressure ulcers in spinal cord injury patients.2014
Role of platelet-rich plasma in healing diabetic foot ulcers: a prospective study.2018
Randomised double-blind placebo controlled trial of topical autologous platelet lysate in venous ulcer healing.2000
Comparison of platelet-rich plasma gel in the care of the pressure ulcers with the dressing with serum physiology in terms of healing process and dressing costs.2020
Autologous Platelet-Rich Gel for the Treatment of Diabetic Sinus Tract Wounds: A Clinical Study.2020
Comparison of Efficacy of Autologous Platelet-Rich Fibrin versus Unna's Paste Dressing in Chronic Venous Leg Ulcers: A Comparative Study.-- Not Found --
Autologous platelet-rich plasma for treatment of venous leg ulcers: a prospective controlled study.-- Not Found --
LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial.2018
Autologous platelet-rich gel for lower-extremity ischemic ulcers in patients with type 2 diabetes2017
Skin grafting and topical application of platelet gel in the treatment of vascular lower extremity ulcers2014
The Effect of Platelet Rich Plasma Dressing on Healing Diabetic Foot Ulcers2016
The Study Of The Effectiveness Of The Drug Combination Of Collagen And Platelet-Rich Plasma For The Regional Treatment Of Venous Ulcers.2017

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