Phase 3, Double-blind, Placebo-Controlled Study of RECCE®327 Topical Gel for the Treatment of Diabetic Foot Ulcer Infections

Tahapan Penelitian : Initial
Sponsor:
Mitra Pelaksana:
PT Increase Laboratorium Indonesia (INCREASE), Siloam Hospitals Denpasar, Rumah Sakit Universitas Udayana, Rumah Sakit Universitas Airlangga, RSUP Fatmawati, Siloam Hospitals Lippo Village
No Registry
INA-7C55L86A
Tanggal Input Registry : 02-09-2025

15-09-2025
Clinical response of the Diabetic Foot Infection (DFI) according to the Lipsky Scale
Clinical response of the Diabetic Foot Infection (DFI)
 
Phase 3, Double-blind, Placebo-Controlled Study of RECCE®327 Topical Gel for the Treatment of Diabetic Foot Ulcer Infections
Phase 3, Double-blind, Placebo-Controlled Study of RECCE®327 Topical Gel for the Treatment of Diabetic Foot Ulcer Infections
Interventional
After the wound is cleaned with saline, a generous amount of RECCE®327 topical gel should be applied in sufficient quantity to cover the infected ulcer and peri -wound area, once daily for seven (7) days to the DFI, followed by safety and efficacy evaluations. If deemed necessary by the Investigator (that is, the wound is not yet cured), up to an additional seven (7) days of topical gel may be applied with repeat safety and efficacy evaluations at the end of the treatment period. After each application of the study medication, a non-absorbent wound dressing will be applied to the wound (ulcer). Footwear to off load the wound due to location, will be allowed. Participants will receive study medication for up to 14 days. At any point in the study, the Investigator may determine that the participant is not responding to study medication and remove the participant from the study. The participant will be deemed a treatment failure. The Investigator may then start the participant on the standard of care for treatment of an infected diabetic foot ulcer at their discretion.
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Inclusion Criteria:

Age ≥18 years at screening with suitability confirmed by screening assessments including ability to understand and provide written informed consent or equivalent., Must be able to read and understand study information sheet and must give voluntary written informed consent prior any study assessment., Body Mass Index (BMI) < 41 kg/m²., Female participants must: Be of non-child-bearing potential or surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the Screening Visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or If of child-bearing potential, must have a negative serum pregnancy test before the first study drug administration (Day 1). They must agree not to attempt to become pregnant, must not donate ova for a minimum of 28 days after last study drug administration, and must agree to: Use at least one form of highly effective contraceptive method between signing consent, during the study, and at least 28 days after the last dose of study therapy. Women of childbearing potential with same sex partners (abstinence from penile vaginal intercourse) are eligible when this is their preferred and usual lifestyle., Diagnosed diabetes mellitus (Type I or II) with a haemoglobin A1c 1 cm beyond edge of wound or abscess); Pus formation;., Palpable pedal pulse., Creatinine clearance > 60 mL/min., Non-hospitalized and ambulatory (with assistance if need be) Can wear footwear which offloads the ulcer, if necessary., In the opinion of the investigator, the participant can undertake and complete all study procedures as outlined in the protocol., No antibiotic treatment within 48 hours of Day 1 unless approved by the sponsor medical monitor

Exclusion Criteria:

Pregnant or breastfeeding/ lactating women., History of current clinically significant medical history or condition which would preclude participation in the judgment of the Principal Investigator and Sponsor’s Medical Monitor., Participant has received immunotherapy treatment within 90 days of Day 1 visit., Currently suffers from clinically significant systemic allergic disease, or has a history of significant drug allergies, or risk factors for treatment adverse effects, including but not limited to ( History of type I hypersensitivity to any medication Intolerance to PEG;Known hypersensitivity to any component of the formulation of test article (RECCE®327)., Ulcer has an exposed tendon, capsule, or bone.,IDSA defined DFU infection as Moderate or Severe., DFU infected ulcer associated with prosthetic device or surgical hardware., Ulcer is currently being treated with topical antimicrobial treatment which is responding to therapy., Participant has received systemic antibiotics within 48 hours prior to screening., Use of any investigational products within 30 days prior to the first dose of study medication., Documented peripheral arterial disease with ankle brachial indices ≤ 0.4 or toe brachial indices < 0.5 or toe pressure < 40 mmHg (documented brachial indices or pressures not mandatory for the study)., Participant has acute active Charcot foot., Clinically relevant abnormalities found in physical examination, vital signs measurements, laboratory safety tests., Is an immediate family member of the investigator, or is an employee of the study centre, or is in dependent relationship with a study centre’s employee who is involved in the conduct of this study or may consent under duress.
 
No. 158/KEP/2025 tanggal 13 Agustus 2025
Not applicable
PPUK/PPUB number
Not Specified
M. Ikhsan Jufri, Goldyna Marthasya Simanjuntak