Trial abstract
LL37-PH1-2-VENOUSULCER — structured trial abstract
LL37-PH1-2-VENOUSULCER — LL-37 in wound healing: randomised, double-blind, placebo-controlled
§1Structured abstract
§1.1Objective
To evaluate LL-37 in cutaneous wound healing and tissue repair, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Double-blind (participant, investigator and sponsor)
- Phase
- Phase 1/2
- Randomised participants
- 34
- Duration of the primary analysis period
- 4 weeks
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Change in ulcer area after topical administration
§1.4Principal result
A dose-dependent reduction in ulcer area at the low and intermediate doses only, with no effect at the highest dose.
A non-monotonic dose–response is a finding the Institute reports rather than smooths over.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Extracted | Reproduced as published. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |
Compound Evidence Institute · CEI-TR-0116 · https://compoundevidence.com/trials/ll37-ph1-2-venousulcer/ · retrieved 30 July 2026