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Clinical Studies

Risk Factors for Development of DFU’s

  • Neuropathy

  • Peripheral Vascular Disease (ischemia)

  • Hperglycemia

  • Trauma with predisposition to secondary infection

Human Compassionate Use Cases.

Physicians in countries where rhPDGF is marketed have already successfully employed an off-label form of ABSOLVE Bioactive Wound Dressing for the successful treatment of end stage DFUs. Since this use is currently off-label the DFUs treated were limited to the most severe and non-responsive wounds with the only available alternative deemed to be amputation. Several such cases are shown here. The treating physicians described the clinical results as “dramatic”. These human cases demonstrate the promising results that may be achieved using ABSOLVE to heal wounds faster.

rhPDGF-BB

Human Proof Concepts

First patient treated with rhPDGF impregnated collagen wound dressing. The patient underwent a lesser toe amputation which resulted in a diabetic ulcer that at its biggest measured 2cm across and 1 cm deep. The ulcer was treated a collagen wound dressing to which had been added solution containing rhPDGF. The following photo was taken after removing this dressing at 10 days. Healing is remarkable.

This patient was a diabetic and smoker. A failed previous mid foot bony fusion developed into a large dermal ulcer post hardware removal. The ulcer was first treated with negative pressure wound therapy for 5 weeks at a cost of around $5K (USD). The results were disappointing. The wound was subsequently re-debrided and collagen wound dressing soaked with a rhPDGF solution was placed.

Any remaining rhPDGF/wound dressing was removed after 10 days (not photographed) and the wound was deemed to be successfully granulated such that a standard dressing was used from this point on. During therapy patient was weight bearing and continued to work.  Post-tx photos are at 5 weeks after the rhPDGF soaked wound dressing treatment.

This patient underwent an aggressive greater toe and forefoot amputation. Primary closure was not possible and the wound was dressed with a collagen wound dressing soaked in/rhPDGF upon release from the operating room. The patient was then treated with one more application of a rhPDGF soaked wound dressing around 10 days later in a ward setting and the patient wen on to heal. The time frame from the initial amputation to the most healed photo is 6 weeks.

This diabetic patient had already lost one leg due to partial foot amputation that would not heal and ultimately became infected. The other foot subsequently also developed a large non-healing ulcer. The treating vascular surgeon felt rhPDGF was the only chance at saving the other leg. A collagen wound dressing soaked with rhPDGF was applied and the wound left undisturbed  for 4 weeks, at which point the wound was cleaned. The patient and the surgeon were overjoyed with the resultant healing, which  continued to progress.