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Study · Randomized controlled trial · 2023

5 results

Efficacy of LL-37 cream in enhancing healing of diabetic foot ulcer: a randomized double-blind controlled trial.

Miranda E, Bramono K, Yunir E, Reksodiputro MH, Suwarsa O, Rengganis I, Harahap AR, Subekti D, Suwarto S, Hayun H, Bardosono S, Baskoro JC

Archives of dermatological research22 Jul 2023Cited by 27 (Europe PMC)

PMID37480520 (opens in a new tab)PMCIDPMC10514151 (opens in a new tab)DOI10.1007/s00403-023-02657-8 (opens in a new tab)PepBankPUB-37480520
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Summary

Wound healing in DFU (diabetic foot ulcer) has prolonged inflammation phase and defective granulation tissue formation. LL-37 has antimicrobial property, induces angiogenesis, and keratinocyte migration and proliferation. This study analyzes the efficacy of LL-37 cream in enhancing wound healing rate and decreasing the levels of IL-1α, TNF-α, and the number of aerobic bacteria colonization in DFU with mild infection. This study was conducted from January 2020 to June 2021 in Jakarta. Subjects were instructed to apply either LL-37 cream or placebo cream twice a week for 4 weeks. Wounds were measured on days 7, 14, 21, and 28 and processed with ImageJ. The levels of LL-37, IL-1α, and TNF-α from wound fluid were measured using ELISA. The number of aerobic bacteria colonization was counted from the isolate grown in culture. The levels of LL-37 in DFU at baseline were equally low in both groups which were 1.07 (0.37-4.96) ng/mg protein in the LL-37 group and 1.11 (0.24-2.09) ng/mg protein in the placebo group. The increase in granulation index was consistently greater in the LL-37 group on days 7, 14, 21, and 28 (p = 0.031, 0.009, 0.006, and 0.037, respectively). The levels of IL-1α and TNF-α increased in both groups on days 14 and 21 (p > 0.05). The decrease in the number of aerobic bacteria colonization was greater in the LL-37 group on days 7, 14 and 21, but greater in the placebo group on day 28 (p > 0.05). In conclusion, LL-37 cream enhanced the healing rate of DFU with mild infection, but did not decrease the levels of IL-1α and TNF-α and the number of aerobic bacteria colonization. This trial is registered at ClinicalTrials.gov, number NCT04098562.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with diabetic foot ulcer, topical LL‑37 cream increased the granulation index more than placebo cream on days 7, 14, 21 and 28.

    In plain wordsIn people with diabetic foot ulcers, LL‑37 cream improved granulation tissue formation more than placebo cream.

    Peptide
    LL-37
    Outcome
    IncreaseIncrease in granulation index on days 7, 14, 21 and 28
    Study

    n: not reported in source

    Comparator
    Placebo cream
    Outcome group
    Wound healing · Skin and wound
    Studied dose
    Dose not stated · topical cream · 4 weeks, applied twice a weekAs given in this study (human).

    Source sentences

    Summary
    The increase in granulation index was consistently greater in the LL-37 group on days 7, 14, 21, and 28 (p = 0.031, 0.009, 0.006, and 0.037, respectively).
    1 context sentence
    Summary · context
    Subjects were instructed to apply either LL-37 cream or placebo cream twice a week for 4 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with diabetic foot ulcer, LL‑37 cream did not decrease wound-fluid IL-1α; levels increased in both groups on days 14 and 21 (p > 0.05).

    In plain wordsIn people with diabetic foot ulcers, LL‑37 cream did not lower the inflammation marker IL-1α in wound fluid.

    Peptide
    LL-37
    Outcome
    No significant changeIL-1α level in wound fluid
    Study

    n: not reported in source

    Comparator
    Placebo cream
    Outcome group
    Inflammation markers · Skin and wound
    Studied dose
    Dose not stated · topical cream · 4 weeks, applied twice a weekAs given in this study (human).

    Source sentences

    Summary
    The levels of IL-1α and TNF-α increased in both groups on days 14 and 21 (p > 0.05).
    Summary
    did not decrease the levels of IL-1α and TNF-α
    1 context sentence
    Summary · context
    Subjects were instructed to apply either LL-37 cream or placebo cream twice a week for 4 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with diabetic foot ulcer, LL‑37 cream did not decrease wound-fluid TNF-α; levels increased in both groups on days 14 and 21 (p > 0.05).

    In plain wordsIn people with diabetic foot ulcers, LL‑37 cream did not lower the inflammation marker TNF-α in wound fluid.

    Peptide
    LL-37
    Outcome
    No significant changeTNF-α level in wound fluid
    Study

    n: not reported in source

    Comparator
    Placebo cream
    Outcome group
    Inflammation markers · Skin and wound
    Studied dose
    Dose not stated · topical cream · 4 weeks, applied twice a weekAs given in this study (human).

    Source sentences

    Summary
    The levels of IL-1α and TNF-α increased in both groups on days 14 and 21 (p > 0.05).
    Summary
    did not decrease the levels of IL-1α and TNF-α
    1 context sentence
    Summary · context
    Subjects were instructed to apply either LL-37 cream or placebo cream twice a week for 4 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with mildly infected diabetic foot ulcer, the decrease in aerobic bacteria colonization with LL‑37 cream versus placebo cream was not significant (p > 0.05); it was greater with LL‑37 on days 7, 14 and 21 and greater with placebo on day 28.

    In plain wordsIn people with mildly infected diabetic foot ulcers, LL‑37 cream did not clearly reduce bacteria counts compared with placebo cream.

    Peptide
    LL-37
    Outcome
    No significant changeNumber of aerobic bacteria colonization
    Study

    n: not reported in source

    Comparator
    Placebo cream
    Outcome group
    Infection and antimicrobial activity · Infection
    Studied dose
    Dose not stated · topical cream · 4 weeks, applied twice a weekAs given in this study (human).

    Source sentences

    Summary
    The decrease in the number of aerobic bacteria colonization was greater in the LL-37 group on days 7, 14 and 21, but greater in the placebo group on day 28 (p > 0.05).
    1 context sentence
    Summary · context
    Subjects were instructed to apply either LL-37 cream or placebo cream twice a week for 4 weeks.

Natural levels measured1

These results measure the body's own peptide. Nobody was given the peptide. They are not evidence about taking it. They are left out of key results, evidence counts and charts.

  1. 05HumanEndogenous levelRandomized controlled trialOther

    In patients with diabetic foot ulcer, baseline natural LL‑37 levels in wound fluid were reported as low and equal in both groups (1.07 and 1.11 ng/mg protein).

    In plain wordsIn people with diabetic foot ulcers, the body's own LL‑37 levels in wound fluid were low before treatment in both groups.

    Peptide
    LL-37
    Outcome
    Not applicableBaseline LL-37 level in wound fluid of diabetic foot ulcers
    Study

    n: not reported in source

    Outcome group
    Wound healing · Skin and wound

    Measurements

    Baseline wound fluid LL-37
    1.07 ng/mg protein
    LL-37 cream group at baseline; abstract gives range 0.37-4.96
    Baseline wound fluid LL-37
    1.11 ng/mg protein
    Placebo cream group at baseline; abstract gives range 0.24-2.09

    Source sentences

    Summary
    The levels of LL-37 in DFU at baseline were equally low in both groups which were 1.07 (0.37-4.96) ng/mg protein in the LL-37 group and 1.11 (0.24-2.09) ng/mg protein in the placebo group.
    1 context sentence
    Summary · context
    The levels of LL-37, IL-1α, and TNF-α from wound fluid were measured using ELISA.

    This result measures the body's own LL-37. Nobody was given the peptide. It is not evidence about taking it.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 2NCT04098562

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

Fakultas Kedokteran Universitas Indonesian = 40est. Oct 2019 to est. Jan 2020

Diabetic Foot Ulcer

Trial pageClinicalTrials.govUpdated 25 Sept 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    9 Oct 2026, 12:39 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:03 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 02:56 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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