Diabetic Foot UlcerPhase 2NCT04098562
Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers
A Phase 2 study testing LL37 and Standard Wound Care in people with Diabetic Foot Ulcer, run by Fakultas Kedokteran Universitas Indonesia at 3 sites in Indonesia.
Trial summary
Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- LL37 and Standard Wound Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesIndonesia
- Study dates
- Oct 2019to Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to 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
- Subjects are willing to participate by signing consent
Who cannot join
- Gangrene
- 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
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
RS Persahabatan
Jakarta, DKI Jakarta, 13230
Eliza Miranda, MD, +628119001018, elisamiranda74@yahoo.com
Eliza Miranda, MD
RS Pusat Angkatan Darat Gatot Soebroto
Jakarta Pusat, DKI Jakarta, 10410
Eliza Miranda, MD, +628119001018, elisamiranda74@yahoo.com
Eliza Miranda, MD
RSUPN dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
Eliza Miranda, MD, +628119001018, elisamiranda74@yahoo.com
Eliza Miranda, MD
About this study
Official title: The Efficacy of LL-37 Cream on Aerobic Bacteria Colonization Pattern, Inflammation Response: Interleukin 1α (IL-1α) and Tumor Necrosis Factor α (TNF-α), and Healing Rate of Diabetic Foot Ulcers
Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. 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. Various substances and modalities are being investigated for their potential effects in treating DFU, one of which is LL-37.
In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled. Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream (treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound care. The primary outcomes are the healing rate measured by wound area and granulation index and changes in patterns of aerobic bacteria colonization during the 4-week study duration and changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the second and third week of study compared to baseline.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- LL37, Standard Wound Care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LL37Drug
cream
Standard Wound CareProcedure or surgery
Standard wound debridement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks Receives: Drug: LL37; Procedure: Standard Wound Care |
| Placebo | Placebo comparator | Placebo cream, administered twice a week for 4 weeks Receives: Procedure: Standard Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Healing Rate at 1 Week
Measured by difference of granulation index by ImageJ
Measured: Changes from baseline of granulation index at 1 week
Changes of Healing Rate at 2 Week
Measured by difference of granulation index by ImageJ
Measured: Changes from baseline of granulation index at 2 weeks
Changes of Healing Rate at 3 Week
Measured by difference of granulation index by ImageJ
Measured: Changes from baseline of granulation index at 3 weeks
Changes of Healing Rate at 4 Week
Measured by difference of granulation index by ImageJ
Measured: Changes from baseline of granulation index at 4 weeks
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 1 Week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Measured: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 1 week
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 2 Week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Measured: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 2 week
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 3 Week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Measured: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 3 week
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 4 Week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Measured: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 4 week
Changes of Inflammation Marker at 2 Week
Measured by the concentrations of IL-α and TNF-α by ELISA
Measured: Changes from baseline at the end of second week
Changes of Inflammation Marker at 3 Week
Measured by the concentrations of IL-α and TNF-α by ELISA
Measured: Changes from baseline at the end of third week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliza Miranda, MD, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Eliza Miranda, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098562
- Sponsor's protocol ID
- 19-09-1128
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miranda E, Bramono K, Yunir E, Reksodiputro MH, Suwarsa O, Rengganis I, Harahap AR, Subekti D, Suwarto S, Hayun H, Bardosono S, Baskoro JC. Efficacy of LL-37 cream in enhancing healing of diabetic foot ulcer: a randomized double-blind controlled trial. Arch Dermatol Res. 2023 Nov;315(9):2623-2633. doi: 10.1007/s00403-023-02657-8. Epub 2023 Jul 22.
PubMed 37480520
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of LL-37 Cream on Aerobic Bacteria Colonization Pattern, Inflammation Response: Interleukin 1α (IL-1α) and Tumor Necrosis Factor α (TNF-α), and Healing Rate of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04098562
- Acronym / sponsor ID
- 19-09-1128
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. 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. Various substances and modalities are being investigated for their potential effects in treating DFU, one of which is LL-37.
In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled. Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream (treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound care. The primary outcomes are the healing rate measured by wound area and granulation index and changes in patterns of aerobic bacteria colonization during the 4-week study duration and changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the second and third week of study compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: LL37, Procedure: Standard Wound Care0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks |
| Placebo | Placebo comparator | Procedure: Standard Wound CarePlacebo cream, administered twice a week for 4 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Gangrene
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LL37cream | Drug | Treatment |
| Standard Wound CareStandard wound debridement | Procedure or surgery | Placebo, Treatment |
Primary outcome
Changes of Healing Rate at 1 Week
Time frame: Changes from baseline of granulation index at 1 week
Measured by difference of granulation index by ImageJ
Changes of Healing Rate at 2 Week
Time frame: Changes from baseline of granulation index at 2 weeks
Measured by difference of granulation index by ImageJ
Changes of Healing Rate at 3 Week
Time frame: Changes from baseline of granulation index at 3 weeks
Measured by difference of granulation index by ImageJ
Changes of Healing Rate at 4 Week
Time frame: Changes from baseline of granulation index at 4 weeks
Measured by difference of granulation index by ImageJ
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 1 Week
Time frame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 1 week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 2 Week
Time frame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 2 week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 3 Week
Time frame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 3 week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 4 Week
Time frame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 4 week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Changes of Inflammation Marker at 2 Week
Time frame: Changes from baseline at the end of second week
Measured by the concentrations of IL-α and TNF-α by ELISA
Changes of Inflammation Marker at 3 Week
Time frame: Changes from baseline at the end of third week
Measured by the concentrations of IL-α and TNF-α by ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 37480520Miranda E, Bramono K, Yunir E, Reksodiputro MH, Suwarsa O, Rengganis I, Harahap AR, Subekti D, Suwarto S, Hayun H, Bardosono S, Baskoro JC. Efficacy of LL-37 cream in enhancing healing of diabetic foot ulcer: a randomized double-blind controlled trial. Arch Dermatol Res. 2023 Nov;315(9):2623-2633. doi: 10.1007/s00403-023-02657-8. Epub 2023 Jul 22.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot Ulcer
Recruiting
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Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliza Miranda, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LL37 and Standard Wound Care in people with Diabetic Foot Ulcer, run by Fakultas Kedokteran Universitas Indonesia at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eliza Miranda, MD (+628119001018, elisamiranda74@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Healing Rate at 1 Week (time frame: Changes from baseline of granulation index at 1 week). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04098562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.