Use of autologous PRP for the treatment of diabetic foot ulcers

Driver et al. (2006) carried out the first reported prospective, randomized, controlled multicentre trial in the United States regarding the use of autologous PRP for the treatment of diabetic foot ulcers.

Purpose: to compare the effectiveness of autologous PRP gel, to that of normal saline gel for 12 weeks. The primary objective of this study was to evaluate the safety of PRP and the incidence of complete wound closure, defined as 100% re-epithelialization, when compared to the control treatment, and a secondary objective was rate of wound closure.

Patient number: 72 patients with type 1 and type 2 diabetes ( aged 18 to 95)

Conditions treated: patients suffering from an ulcer of at least four weeks duration.

Study duration: 12 weeks with patients evaluated biweekly

Findings: After exclusion of 32 patients due to trial protocol violations – no completion etc, the authors found that 68.4 % (13/19) patients in the PRP group, and 42.9 % (9/21) in the control group had wounds that healed. Wounds in the PRP group healed after a mean of 42.9 days vs. 47.4 days in the control group. After adjusting for wound size outliers significantly more PRP gel (81.3%) than control gel (42.1%) treated wounds healed

Conclusion: When used with good standards of care, the majority of non-healing diabetic foot ulcers treated with autologous platelet-rich plasma gel can be expected to heal.

Treatment of chronic lower-extremity ulcers with platelet-rich fibrin matrix (PRFM).

O’Connell et al. (2008) presented promising findings from a pilot study involving the treatment of chronic lower-extremity ulcers with autologous platelet-rich fibrin matrix membrane (PRFM).

Purpose: to test improvement in healing time with use of PRFM for lower extremity ulcers

Patient number: 21 ( aged 18 to 85)

Conditions treated: 12 patients with 17 venous lower-extremity ulcers ( VLU); nine patients with 13 non-venous lower-extremity ulcers (NVLU), all who had failed to respond to at least four weeks of conventional treatment.

Study duration: 12 weeks with follow-up at one month.

Findings: Complete healing was achieved in 66.7% patients with VLU in 7.1 weeks (median six weeks) following an average of two applications of PRFM per patient. Of the NVLU group, 44% patients treated with PRFM healed completely during the study period.

Conclusion: Although this study is limited as a small-scale pilot, it suggests that platelet-rich substances such as PRFM have the potential to heal chronic lower-extremity ulcers that have failed to heal by conventional methods

Evaluate Healing Lower Extremity Wounds in Patients with Diabetes

Sakata, J. et al., (2012) Retrospective Diabetic Ulcer Trial to Evaluate Healing Lower Extremity Wounds in Patients with Diabetes Mellitus and Ischemia Using Standard Protocols of Care and Platelet-Rich Plasma Gel in a Japanese Wound Care Program.

Purpose: To compare PRP therapy to standard wound care on wound healing times and success in chronically unwell patients with significant co-morbidities ( real world)

Patient number: 39 patients with 40 wounds. 85% patients had DM; median age was 66.8 years ; patients in poor health with comorbidities including chronic renal failure (44%), stroke (21%), hypertension (15%) and others (10%).

Conditions treated: chronic, non-healing severe wounds on the lower extremities (Wagner classification of III or higher) that were treated with various levels of standard of care therapy prior to escalation to PRP gel. All wounds were infected and had been treated with systemic antibiotics. 70% of diagnosed wounds were ischaemic. By the time patients came to the Wound Care Centres, their wounds had persisted for an average of 99.7 days. Patients received treatment before PRP gel consisting of debridement, offloading, revascularization, NPWT, treatment of infections, and wound dressings for an average of 75.3 days, but during this time the average wound actually increased with statistical significance in size and severity.

Findings: The mean treatment period with PRP was 45.4 days, and 33/40 wounds (83%) healed completely, in an average time of 145 days. The average patient received 6.1 treatments with PRP. For patients with DM, 19/24 wounds (79%) healed in an average of 108 days.

Conclusion:  The results of this study suggest that good healing outcomes and a low amputation rate can be obtained with a protocol of supportive care (in­cluding revascularization procedures) and the PRP gel treatment.

Restart healing cascade in chronic wounds with PRP

Frykberg, et al (2010) looked at whether PRP could restart the healing cascade in chronic wounds due to the prior long inflammatory phase that hinders regenerative wound healing.

Purpose: to evaluate how a physiologically relevant concentration of an autologous platelet-rich plasma (PRP) gel affects initial wound healing trajectories of chronic, non-healing wounds of various etiologies and in different care settings

Patient number: 65 non-healing wounds in 49 patients at 8 hospitals and 3 wound clinics; average age 66y

Conditions treated: The wounds had persisted for an average of 47.8 weeks, and the most persistent wounds had lasted 260 weeks. Common non-healing wounds included diabetic foot ulcers, pressure wounds, and venous ulcers. The mean area of the wounds examined in this study was 19 cm2

Study duration:

Findings: After an average of 2.8 weeks and 3.2 AutoloGel applications, the mean wound area had decreased by 39.5%, undermining reduced by 77.8% and sinus tract by 45.8%. For all wound etiologies, 97% of all wounds in the study experienced clinical improvement after PRP application.

Conclusion: The results of this study suggest the application of this PRP gel can reverse non-healing trends in chronic wounds

Efficiency of platelet-rich plasma (PRP) on the healing of chronic diabetic ulcers

Saad Setta et al. (2011) investigated the efficiency of platelet-rich plasma (PRP) on the healing of chronic diabetic ulcers

Purpose: To compare healing rates between platelet-rich plasma (PRP) in comparison with platelet-poor plasma (PPP), and assess effect of platelet concentration on healing for skin ulcers

Patient number: 24 systematically randomized into two equal number groups: PRP group, PPP group

Conditions treated: chronic diabetic ulcers.

Findings : the results showed that healing in PRP group was significantly faster than PPP

Conclusion : The authors concluded that PRP enhances healing of chronic diabetic foot ulcers. 

Chronic wound healing outcomes with short term PRP use

de Leon et al. (2011) investigated clinical outcomes in chronic non-healing wounds following the short-term use of a platelet-rich plasma (PRP) gel.

Purpose: a large, observational case series using a multicentre registry database (all wounds included), which compared different populations within the database with the putcomes of chronic wounds post PRP therapy.

Patients number: 200 patients, 285 chronic wounds

Conditions treated: diabetic, pressure, or venous ulcer; dehisced, surgical, or traumatic wound; and wounds of other etiologies.

Findings: A positive response occurred in 96.5% of wounds within 2.2 weeks with average of 2.8 treatments. In 86.3% of wounds, 47.5% area reduction occurred, and 90.5% of wounds had a 63.6% volume reduction.

Conclusion: The authors concluded that in chronic wounds recalcitrant to other treatments, utilization of PRP gel can restart the healing process. Rapid treatment response was observed in 275 of 285 wounds, and the magnitude of response was consistently high, with statistically significant outcomes reported for various subgroups

PRP in management of pressure ulcers in spinal cord injury patients

Singh et al.(2014) assessed the role of local application of autologous platelet-rich plasma in the management of pressure ulcers in spinal cord injury patients

Purpose: The objective of this study is to evaluate the local application of platelet-rich plasma (PRP) in relation to pressure ulcers (PrUs) healing on one PrU (case) versus saline dressing on another PrU (control) in the same patient.

Patient number: 25 spinal cord injury patients with at least two PrUs were included.

Conditions treated: All 25 PrUs (case) were grade IV, and PrUs (control) were grade II (n=11), grade IV (n=10) and grade III in 4 patients.

Study duration:

Findings: Evaluation of PrU healing was done by measuring wound surface area, Pressure Ulcer Scale for Healing (PUSH), biopsy and clinical examination. 24 (96%) PrUs improved and only 1 deteriorated with PRP therapy, whereas in control group 17 (68%) PrUs improved, 7 (28%) deteriorated and 1 wound showed no change.

Conclusion: Advanced wound therapy using local applications of PRP seems to be a promising alternative to standard saline dressings in PrU healing. With the advantages of simple preparation, biocompatible safety, low cost and significant clinical effectiveness, it may be beneficial to study the effects of PRP in large-scale trials to validate it as an ideal therapy for enhanced wound healing in PrUs.

Efficacy of PRP in treatment of chronic non-healing ulcers

Suryanarayan et al. (2014) to evaluate the efficacy of platelet-rich plasma (PRP) in the treatment of chronic non-healing ulcers

Patient number: A nonrandomized, uncontrolled study was performed on 24 patients. Mean age 42.5y

Conditions treated: 33 nonhealing ulcers of various etiologies- 19 venous ulcers, 7 traumatic ulcers, 2 ulcers secondary to pyoderma gangrenosum, 2 diabetic ulcers, 2 trophic ulcers, and 1 vasculitic ulcer

Study duration: All patients were treated with PRP at weekly intervals for a maximum of 6 treatments.

Findings:  The mean duration of healing of the ulcers was 5.6 weeks. The mean percentage of reduction in area and volume of the ulcers was 91.7% and 95% respectively. About 100% resolution in the area was seen in 25 (76%) of the ulcers and 100% reduction in volume was seen in 24 (73%) of the ulcers at the end of the 6th treatment

Conclusion: Conventional therapies do not provide satisfactory healing for chronic nonhealing ulcers as they are not able to provide the necessary growth factors which are essential for the healing process. PRP is a safe, affordable, biocompatible, and simple office-based procedure for the treatment of non-healing ulcers.

Efficacy of PRP for intractable skin ulcers

Kakudo et al (2012)  to report on the efficacy of PRP prepared using the Magellan® Autologous Platelet Separator System for intractable skin ulcers such as diabetic and venous ulcers.

Patient number: 5, mean age 54 y

Conditions Treated: chronic ulcers with full-thickness skin or soft tissue defects Ulcer types were venous, diabetic, and pressure ulcers, and ulcers after a low temperature burn injury.

Study duration: maximum 14 weeks

Findings: Application of PRP induced the formation of healthy granulation tissue and allowed successful closure of all wounds. The mean platelet concentration in PRP prepared using the Magellan system was 7.1 times. Epithelialization of the wound took 6.6 weeks on average. The wounds of three patients were completely closed after 4 weeks

Conclusion: No complications occurred in any patients and the wounds achieved complete epithelialization. Our results have shown the efficiency of platelet-rich plasma for the treatment of intractable skin ulcers.

PRF on hard to heal wounds

Steenvoorde et al (2008) retrospectively assessed use of autologous platelet-rich fibrin(PRF) on hard-to-heal wounds

Patient number: 12 patients with 13 wounds. Mean age of 60.5 years

Conditions treated: Hard-to-heal wounds were defined as those with granulation tissue that had failed to epithelialise despite two months’ of conservative treatment. The mean wound duration before treatment with PRF was 15.7 months. PRF was not applied to necrotic or sloughy wounds as thought the platelets would be unable to penetrate the wound bed, or to those with clinical signs of infection. In addition, they all received standard treatment for their condition, such as compression therapy for venous leg ulceration and offloading for diabetic foot ulcers, in the two months before and during treatment with PRF

Study duration: mean number of 2.2 applications. The mean treatment period was 4.2 weeks. These wounds were followed up for between one month and 12 months. 

Findings: 8 (62%) wounds closed and 3 ( 23%)  wounds reduced in diameter by up to 66%. Two wounds did not reduce in size, although one of these did reduce in depth. None of the 8 wounds that healed reopened.

Conclusion: This retrospective study found that use of autologous platelet-rich fibrin on a range of hard-to-heal wounds achieved full healing or a significant reduction in wound diameter with no adverse effects. 

PRP in chronic wounds

Gurgen M ( 2008) prospective study to assess use of PRP in chronic wounds in a dedicated Norwegian wound healing centre

Patient number: Thirteen patients with 14 chronic wounds

Conditions treated: Chronic wounds ( average age of wounds was 8.5 years!) that had not shown signs of epithelialization over 4 week period despite treatment of underlying causes & standard local wound care.

Study duration: 8 months

Findings: 7 days post treatment, ulcer size had reduced by an average of 31% in 11 of 14 wounds. After 28 days, 1 wound had healed completely. Of the remaining ulcers, 12 had decreased in size to an average of  55% of their original size. Average number of PRP treatments was 2.1/patient.

After treatment with platelet-rich plasma, 50% of the wounds had healed, 35.7% had reduced in size and 14.2% were unchanged in terms of area and condition. Recurrences were not observed during the follow-up period of an average of 34.5 weeks

Conclusion: The use of autologous PRP should be reserved for treatment of recalcitrant wounds where there is lack of improvement despite treatment of underlying causes and good local wound care.

PRP in acute limb soft tissue wounds

Kazakos K (2008) to assess the benefits of using autologous PRP gel in the treatment of acute limb soft tissue wounds. The clinical endpoint was the time required to bring about adequate tissue regeneration in order to undergo reconstructive plastic surgery.

Patient number: 59 patients were randomised into two groups. Group A (32patients) were treated with conventional dressings and Group B (27 patients) were managed with local application of PRP gel.

Conditions treated: acute wounds (open fractures, closed fractures with skin necrosis and friction burns). The control Group A included 32 patients with acute trauma wounds which were treated with conventional methods-  topical washing and cleaning of the wounds, removal of the necrotic tissues as appropriate,and dressing with Vaseline gauze every 2 days. The PRP Group B included 27 patients with acute trauma wounds which were treated with local application of PRP gel.

Study duration: 7 weeks

Findings: In Group A patients, the mean time required to bring about adequate tissue regeneration was 40 days.  In Group B, the time required to bring about adequate tissue regeneration in order to undergo reconstructive plastic surgery was in all patients 3 weeks, except one patient who needed 4 weeks

Conclusion: This study has shown that PRP gel treatment can be a valuable and effective aid in the management of acute trauma wounds. This system may be of particular relevance in hospitals which do not have an on-site team of plastic surgeons and patients are treated exclusively under the care of orthopaedic surgeons

PRP optimise local healing environment for patients with recalcitrant ulcers

Kim D (2012) . A case report of assessed the ability of platelet-rich plasma (PRP) to introduce increased concentrations of growth factors and other bioactive molecules to injured tissues in an attempt to optimise the local healing environment for a patient with a recalcitrant cutaneous ulcer and various comorbidities

Patient number: 1- 94 year old woman with various comorbidities

Conditions treated: a severe cutaneous ulcer on the left dorsum of foot, caused by recurrent mechanical trauma and did not respond to several wound debridement and simple dressings.

Study duration

Findings: after she was completed on seven times of autologous PRP treatments, we observed complete healing of the skin lesion within 3 months, after 7 applications of PRP

Conclusion: This report showed the favourable outcome of the refractory cutaneous ulcer using autologous PRP