Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers

What Was Tested

The trial (phase 2) is built around LL-37 (cathelicidin).

Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome.

Wound debridement, infection control, pressure relief and revascularization are main pillars of DFU management.

It had two arms (groups): Treatment (experimental) and Placebo (placebo comparator).

Placebo cream, administered twice a week for 4 weeks.

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with DFU. Ankle brachial index (ABI) 0.9 - 1.3. Wound area 5 - 20 cm\^2. Wound depth until subcutaneous tissue. Without systemic infection, osteomyelitis, septic arthritis, or fasciitis.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: on treatment with systemic corticosteroids within 7 days before the start of study; on treatment with systemic antibiotics within 2 days before the start of study; patients with end stage renal disease.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this LL-37 (cathelicidin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The LL-37 (cathelicidin) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received LL-37 (cathelicidin).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-10 with completion listed for 2019-12.

It ran at 3 sites in Indonesia (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes of Healing Rate at 1 Week (time frame: Changes from baseline of granulation index at 1 week). Changes of Healing Rate at 2 Week (time frame: Changes from baseline of granulation index at 2 weeks). Changes of Healing Rate at 3 Week (time frame: Changes from baseline of granulation index at 3 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of LL-37 (cathelicidin) in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the LL-37 (cathelicidin) compound page, all human trials.