Clinical Outcomes of Topical Recombinant Human Epidermal Growth Factor in Diabetic Foot Ulcers: A Retrospective Single-Centre Cohort Study.

The primary outcome of complete healing of the index ulcer without amputation was recorded in 67.3% of patients.

• The primary outcome occurred in 101/150 patients (67.3%; 95% confidence interval 59.5-74.3).
• The study was a retrospective, single-centre cohort of 150 consecutive patients receiving Regen-D 150, with no control group.
• Treatment was added when standard care did not produce adequate granulation.
• Follow-up was variable.

Sixteen patients underwent amputation, mostly minor.

• Of 16 amputations, 11 were minor and 5 were major.
• This corresponds to 16 of 150 patients in the cohort.
• The authors state the findings do not establish amputation prevention.

A substantial share of patients had ongoing status, died or were lost to follow-up rather than reaching the primary outcome.

• 27 patients had ongoing status at last follow-up.
• Ongoing status included open wounds and closed but unconfirmed wounds.
• Three patients died and three were lost to follow-up.

Median recorded time to healing was 13 weeks.

• The interquartile range was 10-16 weeks.
• The time is based on recorded healing, which could not be confirmed in all cases.
• Follow-up duration varied across patients.

Wound area analyses were exploratory because of unresolved timing inconsistencies in the records.

• The authors flagged timing inconsistencies in the wound area data that were not resolved.
• These analyses were therefore not treated as primary or confirmatory.

Healing could not be confirmed for all recorded healings, and the design limits interpretation.

• The study was retrospective, single-centre, uncontrolled and descriptive.
• The authors conclude the findings do not establish efficacy, superiority or amputation prevention.
• Treatment was added selectively when standard care did not produce adequate granulation.