Estimating the economic value of emerging technologies in chronic wound therapy.

Estimating the economic value of emerging technologies in clinical medicine presents a number of problems. New technologies may have a limited clinical history, few supportive peer-reviewed publications, and only anecdotal evidence as they enter the market and seek clinician approval and reimbursement from payers. Although clinical efficacy/effectiveness research is a minimal starting point for making the case for adoption of a product, establishing a competitive cost-effectiveness position against other products and establishing the case for economic value must be made as well when presenting to health plans or other payers.

Variations in study outcomes relative to intention-to-treat and per-protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft.

Statistical interpretation of data collected in a randomised controlled trial (RCT) is conducted on the intention-to-treat (ITT) and/or the per-protocol (PP) study populations. ITT analysis is a comparison of treatment groups including all patients as originally allocated after randomisation regardless if treatment was initiated or completed. PP analysis is a comparison of treatment groups including only those patients who completed the treatment as originally allocated, although it is often criticised because of its potential to instil bias.

A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers.

Our purpose was to compare healing characteristics of diabetic foot ulcers treated with dehydrated human amniotic membrane allografts (EpiFix®, MiMedx, Kennesaw, GA) versus standard of care. An IRB-approved, prospective, randomised, single-centre clinical trial was performed. Included were patients with a diabetic foot ulcer of at least 4-week duration without infection having adequate arterial perfusion.