Use of Fish Skin Grafting in Diabetic Patients with Known Peripheral Arterial Disease

Introduction: Arterial insufficiency has been discussed as a relative contraindication by some physicians for applying skin substitutes in diabetic patients.  The purpose of this abstract is to evaluate the validity of using fish skin grafting (FSG) in diabetic wounds with known PAD and elevated A1C.  Our hypothesis is that FSG creates vascular ingrowth and neovascularization which aids healing compromised wounds with limited arterial flow in patients with elevated A1C levels.Methods:Criteria for patient selection was only patients with diagnosed diabetes and known PAD.  FSG was performed every 1 to 2 weeks after sharp debridement.  Exclusions made for pressure ulcerations, plantar heel wounds, HBO therapy and immunosuppressive drugs, systemic steroids, or renal replacement therapy.  Index ulcer duration was 4 weeks to less than 1 year, and ulcer size of 1 cm2 to 30 cm2. Inclusion criteria based on perfusion status were as follows: ankle-brachial index between 0.5 and  0.9.  A1C levels were > 8% with no cut off.  Largest A1C in the study was 12.1%.  Graft was affixed with tape and wound dressing was Adaptic with foam outerlayer.  Use of systemic antibiotics during the treatment phase was permitted without removing the patient from the protocol unless the local infection appeared to be a SAE.  No significant use of abx noted and no difference seen between the 2 groups.  Study population of 5 patients was more male than female and age ranged from 52-68 yo.  Average BMI was 35.Results:All wounds went on to complete healing with average time to healing of the wounds in the series was 50 weeks.  The minimum healing time was 30 weeks and maximum was 70 weeks.   Follow up was more than one year after healing in all cases except 1. Only 1 recurrence of wound was noted due to poor fitting shoe gear.  Limitations of the study are small patient population, and single site creating less diversity.  No SAE was encountered and none of the patients had to drop out.Discussion: Complete healing was seen in all cases despite uncontrolled diabetes and significant peripheral arterial disease diagnosed with arterial ultrasound and ankle-brachial index.  Our conclusion is that Fish Skin Grafting provides vascular ingrowth and neovascularization, likely related to omega-3 concentration based on previous studies.  This aids healing in wounds with impaired arterial flow.  We concluded that Fish Skin Grafting is a viable treatment option and not contraindicated in wounds with significant peripheral arterial disease in uncontrolled diabetic patients.References: