Trial Information

A Multicenter Clinical Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers

This single-visit, retrospective study was designed to evaluate the long-term safety of
becaplermin gel 100 mcg/g versus placebo gel. Patients previously enrolled in protocol
PDGF-DBFT-003 or PDGF-DBFT-005 were evaluated during a single-study visit in which
retrospective safety data were collected. Recurrence data on the Target Ulcer were also
obtained. The maximum number of patients in this study was the sum of patients enrolled in
the 2 previous trials. The investigators made every effort to contact all patients enrolled
in the previous double-blind trials in order to get follow-up information on as many
patients as possible. If the patient was deceased, the cause of death, if known, was
collected by the investigator (where permitted by the local authorities). After evaluation
of the entrance criteria, demographic data, significant new intercurrent illnesses, a
current medication profile, therapies received for the treatment of any diabetic neuropathic
foot ulcer and surgeries in the last 12 or more months were collected and recorded. A
questionnaire was used by the investigational staff to elicit patient information. At the
visit, a complete physical examination was done (special attention was given to assess the
presence of any malignancies), the feet were carefully examined and the footwear was
assessed. The site of the Target Ulcer treated in the previous double-blind trial was
assessed by an independent dermatologist.and photographs of the heel, back, inside and
outside surfaces of the foot, as well as a distance photograph of the foot, were taken.
Parameters such as major changes in the general health, (i.e., hospitalizations, major
illnesses, and past surgeries), and past as well as present histories of any malignant
diseases were carefully assessed. Of primary interest were the examination of previously
treated ulcer site(s) and the Target Ulcer limb in general, for recurrences and/or new
ulcerations; their treatments and outcomes; and any other relevant changes to the previously
treated ulcer and the surrounding skin. Observational study - No study drug administered