Introduction
Nearly a quarter of diabetic foot ulcers will result in an amputation. In the US, approximately 1 in 2 people either have diabetes or are pre-diabetic. In 2012, 29 million Americans claimed the diagnosis of diabetes mellitus.
According to the International Diabetes Foundation, there are more than 300 million people living with diabetes worldwide.
Diabetes cost the global economy at least US $376 billion in 2010, or 11.6% of total world healthcare expenditure. To lower morbidity and mortality from diabetic ulcers, prevention is key. Once an ulcer has developed, physicians need safe and affordable ways to care for it.
Traditional wound care, even if meticulous, does not cure all wounds. Despite adding on hyperbarics, expensive dressings and topicals, even arterial bypasses, still there will be some 15%-25% of patients in which the therapies will fail, leaving amputation as their only option for survival.
Purpose
To use Regen Platelet Rich Plasma (PRP) on acute and chronic non-healing wounds and evaluate if it is a cheaper, less invasive, and more efficacious therapy.
Methods
88 year old diabetic US citizen with multiple co-morbitities including coronary artery disease, chronic renal insufficiency, anemia, hypertension, and hypercholesterolemia, developed a foot ulcer. Traditional therapies including topicals, compression wraps, and hyperbarics were not enough. A femoral bypass performed was too late. His left foot was amputated on March 2015. Subsequently he went on to lose his right foot. When he was told that he would need an above the knee amputation, his daughter refused and begged me, a family physician, to save her left father’s leg (that had previously nearly been amputated from an MVA at 29 and a massive burn when he was 22). The patient required dialysis and while the temporary access was being used, he maintained adequate blood supply until the permanent shunt was placed when his left pinky became ischemic. A DRIL procedure was performed too late.
The authors employed PRP, platelet-rich-plasma derived from the patient using the Regen Lab BCT-2 plus kit. When the patient was threatened with a left above the knee amputation (LAKA), PRP treatments were begun. A series of PRP injections and applications were performed on day 1, 4, 13, and 32 following the Regen Lab Protocol 3(see attachments). The patient’s left leg was saved from an AKA.
Results
All of the wounds treated improved or healed totally except for one (the left pinky).
Discussion
When Integra and wound debridement with beveled edges via the expert plastic surgeon did not advance wound healing in our patient, the patient was threatened with amputation. The surgeon gave the authors one week to halt progression and to demonstrate wound healing, otherwise, the AKA would be employed for survival of the patient.
The cost of using the Regen Lab Kit, other wound care supplies, and the doctor’s fees has not been established since it is not yet approved by the FDA or insurance companies. But, the authors estimate the price of saving one’s limb would be preferred over the monetary cost and the risk of the morbidity and mortality of surgery.
A google search for the cost of an amputation above the knee revealed that the surgical financial burden could be upwards of $60,000 and that is not including the physical therapy ($25-350 per session), the cost of a prosthesis $10-$70,000), or the price of the psychosocial damage and restricted mobility repercussions.
Conclusions
PRP application using the Regen BCT Kit directly onto and injection into chronic non-healing and new diabetic wounds enhances wound healing safely and cost-effectively if there is adequate vascular supply.
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