Pivotal diabetic-ulcer program

Study design

Record details

Design: Large pivotal clinical development program reported in contemporary sources.
Population or model: 511 participants in the diabetic-ulcer program.
Material tested: ProCyte/prezatide copper ulcer-treatment program.
Comparator: Controlled pivotal program; exact arm-level details were not located in a peer-reviewed full report.

Evidence record

Endpoints, findings, and limitations

Endpoints

Wound-size reduction and complete wound closure.

Qualified findings

The pivotal program reportedly failed both wound-size and complete-closure endpoints.

The failure prevents the earlier Phase II signal from being presented as an established or approved wound treatment.

Limitations

Exact arm results, safety details, and a peer-reviewed full report were not located. Contemporary sponsor and news reports are the available record. Keep linked to GHK-STUDY-P019.

Reports and sources

Reference ledger

GHK-P020Sponsor trial report

Contemporary reports of ProCyte's 511-participant pivotal diabetic-ulcer program

BioWorld; Seattle Times(1994)
No peer-reviewed full report located. Seattle Times archive: https://archive.seattletimes.com/archive/19941017/1936453/procyte-drug-fails-test-stock-plunges----clinical-trials-cast-doubt-on-companys-future. Must remain linked to GHK-P019.
GHK-P019Primary paper

Enhanced healing of ulcers in patients with diabetes by topical glycyl-L-histidyl-L-lysine copper

Mulder GD; Patt LM; Sanders L et al.. Wound Repair and Regeneration(1994). DOI: 10.1046/j.1524-475X.1994.20406.x
Phase II matched-vehicle comparison. PMID 17147644. Must remain linked to GHK-P020 pivotal failure.