Phase II diabetic-ulcer matched-vehicle comparison

Study design

Record details

Design: Randomized Phase II trial with immediate and delayed-treatment comparisons.
Population or model: 181 people with diabetic lower-extremity ulcers.
Material tested: Prezatide copper acetate in a simple topical gel.
Comparator: The same gel without prezatide copper acetate; delayed-treatment groups were also evaluated.

Evidence record

Endpoints, findings, and limitations

Endpoints

Wound closure, including median percentage closure in the immediate plantar-ulcer comparison.

Qualified findings

The immediate plantar-ulcer comparison favored active treatment, with median closure reported at about 98.5% versus 60.8% with vehicle.

Delayed-treatment arms did not significantly outperform vehicle, and the later pivotal program failed its primary wound outcomes.

Limitations

Sponsor involvement and incomplete access to the full reporting hierarchy limit certainty. This positive signal must always remain paired with the GHK-STUDY-P020 pivotal failure.

Reports and sources

Reference ledger

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.
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.