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

NCT00740922 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 563

Last updated 2011-06-08

No results posted yet for this study

Summary

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 \[neither the physician nor the patient knows the name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005\].

Conditions

  • Platelet-Derived Growth Factor
  • Diabetic Foot
  • Neoplasms

Interventions

DRUG

Sterile becaplermin gel vs. sterile placebo gel treatment 1

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

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

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-07-31
Completion
2001-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00740922 on ClinicalTrials.gov