Clinical trial · Observational

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

NCT00740922CI-TRIAL-00004960completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Diabetic Foot	—	UNRESOLVED	—
Neoplasms	Neoplasm	ONTOLOGY_EXACT	0.90
Platelet-Derived Growth Factor	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Sterile becaplermin gel vs. sterile placebo gel treatment 1	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
1
interventionNames
1. Drug: Sterile becaplermin gel vs. sterile placebo gel treatment 1

Primary outcomes (1)

measure
The primary objective of this study is to retrospectively evaluate the safety of sterile becaplermin gel vs. sterile placebo gel treatment 12 months or more after the last dose was administered.
timeFrame
single visit 12 months after enrollment

Secondary outcomes (1)

measure
The secondary objective of the trial was to evaluate recurrence of the Target Ulcer if it had healed in the previous trial.
timeFrame
single visit 12 months after enrollment

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion Criteria:

* Patients are required to satisfy the following criteria before entering the study: given written informed consent before the performance of any study-related procedures, if deceased, the cause of death, if known, is collected by the investigator (where permitted by the local authorities)
* Received at least 1 dose of study medication in 1 of the double-blind trials PDGF-DBFT-003 or PDGF-DBFT-005 and had any post-baseline data
* A minimum of 12 months elapsed since last study drug dosing in 1 of the double-blind trials PDGF-DBFT-003 or PDGF-DBFT-005

Exclusion Criteria:

* Patients who meet any of the following criteria are excluded from participating in the study: Patients who are unwilling to participate
* Patients who, despite multiple and documented efforts, could not be contacted (the investigator was asked to try at least 3 times to contact the patient or patient's representative or parents by mail and phone)

References

Publications (0)

Data not yet available

No reference posted for this study.