Heart and Blood Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Nervous System Diseases

Rare Diseases

Diabetic Foot

Ulcer

Diabetic Angiopathies

Vascular Diseases

Foot Ulcer

Leg Ulcer

Skin Ulcer

Skin Diseases

Diabetes Mellitus

Diabetes Complications

Endocrine System Diseases

Diabetic Neuropathies

Chronic Graft Versus Host Disease

Anticoagulants

All Drugs and Chemicals

Becaplermin

Angiogenesis Inducing Agents

Becaplermin gel 100 µg/g versus placebo gel (up to 12 applications).

Sterile becaplermin gel vs. sterile placebo gel treatment 1

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials \[neither the physician nor the patient knows the name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005\].

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

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

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

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Clinical Leader, Internal Medicine, EP

Musculoskeletal Diseases

Metabolic Diseases

Glucose Metabolism Disorders

Foot Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Mitogens

Becaplermin users A cohort of becaplermin users (ie patients with diabetes treated with becaplermin)

Becaplermin nonusers A cohort of becaplermin nonusers (ie patients who are not treated with becaplermin but are similar in characteristics to patients in the becaplermin user cohort)

A cohort of becaplermin nonusers (ie, patients who are not treated with becaplermin but are similar in characteristics to patients in the becaplermin user cohort)

Becaplermin nonusers

A cohort of becaplermin users (ie, patients with diabetes treated with becaplermin)

Becaplermin users

The purpose of this study is to evaluate risk of cancer incidence and mortality associated with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S. Veterans Health Administration.

This is an observational study of patients with diabetes who are eligible for care through the national Department of Veterans Affairs Health Care System (VA), representing the largest sample of older adults in an integrated health care system in the U.S. with comprehensive electronic medical records and linkable health survey data. REGRANEX (becaplermin) is topical medication used to treat lower extremity diabetic neuropathic ulcers. VA patients with diabetic foot ulcers who have no prior history of cancer who have received treatment with becaplermin will be compared to a group of similar patients who have not received treatment with becaplermin. Becaplermin users (from the time of initial dispensing of becaplermin) and becaplermin nonusers will be followed forward in time for up to 8 years to identify new cancers and cancer related deaths, with confirmation of cases through registries and medical chart review. This is an observational study; no investigational drug will be administered.

Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes

A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration

Bedford Research Corporation, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers	NCT00740922	Platelet-Derive... Diabetic Foot Neoplasms	Sterile becaple...	-	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers	NCT00740922	Platelet-Derive... Diabetic Foot Neoplasms	Sterile becaple...	-	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes	NCT01235260	Diabetes Mellit... Foot Ulcer Diabetic Foot Diabetic Neurop...	Becaplermin non... Becaplermin use...	- 99 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Spots Global Cancer Trial Database for diabetic foot