ABSTRACT

The effects of purified angiogenic and growth factors from human term placenta in polymeric carrier-dressings were studied during the treatment of chronic venous ulcers. Two double-blind initial clinical trials were carried out. Placental factors incorporated in agar-polyacrylamide dressings were used in the first trial for patients with large ulcers requiring hospitalization. Eighteen patients were randomly assigned to receive a maximum of two dressings either containing or not containing these factors. The amount of granulation and epithelial tissue was clinically estimated 48 hours after each dressing application. Patients receiving placental angiogenic and growth factors showed increased granulation and epithelial tissue. Placental factors incorporated in hydroxyethyl cellulose jelly dressings were used in a second trial for patients with small ulcers (less than 30 cm2 surface area) not requiring hospitalization.

Sixteen patients were randomly allocated to receive dressings either containing or not containing these factors on an out-patient basis at weekly intervals during 12 weeks, with optional crossover midway through the treatment period. Clinical assessment of effects was carried out at each dressing application, as was measurement of ulcer size at alternate dressing applications. Patients receiving placental angiogenic and growth factors showed a mean percentage reduction of 37.24% in ulcer size. Results obtained in these clinical trials indicate that placental angiogenic and growth factors produce enhanced granulation and epithelial tissue formation and an accelerated rate of healing. They also indicate that polymeric dressings are suitable carriers for biologically active growth factors.