ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001202358

Ethics application status

Approved

Date submitted

23/09/2026

Date registered

28/09/2026

Date last updated

28/09/2026

Date data sharing statement initially provided

28/09/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

An Open-Label, Two-Part Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of RECCE®327 Topical Gel in Diabetic-Related Foot Infections: Part B – A Randomized, Active-Controlled, Non-Inferiority Study in Diabetic-related Foot Infections

Scientific title

Additional trial identifiers [1]

RECCE327-G202

Universal Trial Number (UTN)

Trial acronym

Related trial records

ACTRN12624000973516 - Part A

Health condition

Health condition(s) studied:

Diabetic Foot Infections, inclusive of lower leg ulcer infections below the knee

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Part B:
This is a prospective, multi-centre, randomised, open-label, active-controlled Phase 2b/3 study. Adults with mild-moderate infected diabetic foot ulcers limited to skin and subcutaneous tissue, without tendon, ligament, muscle, bone, or joint involvement, are randomised 1:1 to receive once daily RECCE®327 topical gel or physician-selected Standard Of Care (SOC) per Diabetes Feet Australia (DFA)/Australian Diabetes Society (ADS) Australian Guidelines (2021).

All Diabetic Foot Infections (DFI) meeting specified criteria and with International Working Group on the Diabetic Foot (IWGDF) / Infectious Diseases Society of America (IDSA) Infection Grade 2 or Grade 3 limited to skin and subcutaneous tissue, without involvement of tendon, ligament, muscle, bone, or joint tissue, will receive treatment.

Participants randomised to RECCE®327 topical gel will apply the gel once daily, in addition to protocol-specified standard local wound care. Participants randomised to oral antibiotics, will take the antibiotics as prescribed and will also receive Standard of Care (SOC).

For both groups, the initial planned treatment duration is 7 days. If on Day 8 the response is anything other than a cure, treatment will continue, if safe to do so, once daily to Day 14. Study medication may be stopped earlier if, in the investigator’s judgment, this is clinically necessary.

RECCE327 topical gel 4g single use tube. The dose amount will be calculated as follows: weight of tube before application – weight of tube after application = dose amount (g) of RECCE®327 topical gel.

Intervention code [1]

Treatment: Drugs

Description of the comparator or control

The comparator is Physician-selected SOC (oral antibiotic) is administered per Australian Guidelines, in addition to SOC wound care.

One of the following protocol-permitted oral antibiotic regimen will be administered for an initial course of up to 7 days, which may be continued for one additional pre-defined course, for a maximum total of 14 days:

- amoxicillin/clavulanate,
- cephalexin +/- metronidazole,
- doxycycline,
- trimethoprim/sulfamethoxazole.

Control group

Active

Outcomes

Primary outcome [1]

To assess clinical response of diabetic-related foot infection (DFI) to Part B: to compare RECCE®327 topical gel with physician-selected SOC at the End of Treatment (EOT) and confirmed at End of Study (EOS), using the Lipsky Clinical Resolution of Infection Scale (adapted)

Timepoint [1]

End of Treatment (EOT); 7 days up to 14 days of treatment.

Secondary outcome [1]

To characterise the safety and tolerability of RECCE®327 topical gel

Timepoint [1]

Assessed daily from Baseline (pre-treatment) to End of Study (EoS) ; Day 28 after End of Treatment (EOT)

Secondary outcome [2]

To assess the effect of RECCE®327 topical gel on DFI wound status, using the DFI Wound Parameters Score.

Timepoint [2]

Screening (pre-enrolment), Baseline (pre-treatment), Day 8 (post 7 days of treatment), End of Treatment (last day of treatment), End of Study (28 days after End of Treatment)

Secondary outcome [3]

To assess the pharmacokinetic characteristics of RECCE®327 topical gel when applied to mild to moderate DFIs limited to skin and subcutaneous tissue, without tendon, ligament, muscle, bone, or joint involvement using a population pharmacokinetics (PopPK) analysis

Timepoint [3]

Baseline (pre-treatment), Day 8 (7 days of treatment), Day 15 (14 days of treatment for participants on extended treatment)

Eligibility

Key inclusion criteria

- Ages greater than or equal to 18 years at screening, with suitability confirmed by screening
assessments.

- Wound characteristics: Part B: DFI with IWGDF/IDSA classification of Grade 2 (mild infection) or Grade 3 (moderate infection limited to skin and subcutaneous tissue; no
involvement of bone, tendon, ligament, or joint) in a patient with type 1 or
type 2 diabetes. An infection with an open wound is required.

- Adequate limb perfusion as defined in the protocol (e.g., at least one palpable
pedal pulse in the affected limb/s in DFI).

- Body mass index (BMI) greater than or equal to 42.

- Satisfies reproductive, contraception, and breastfeeding requirements.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

- Any diabetic-related foot ulcer (DFU) with exposed tendon, joint capsule, or
bone.

- Any DFU or adjacent structures with confirmed or strongly suspected
osteomyelitis.

- Any DFU infection that extends beyond skin and subcutaneous tissue, such as
infection involving bone, tendon, ligament, or joint tissue.

- Any DFU associated with a prosthetic device or surgical hardware at the site.

- Any DFU currently being treated with topical antimicrobial therapy that is
responding to treatment and where interruption or change of treatment is not
clinically appropriate.

- Oral antibiotics within 48 hours of study Day 1.

- Documented peripheral arterial disease with ankle brachial indices < 0.4 or toe
brachial indices < 0.5 or toe pressure < 40 mm Hg

- Known hypersensitivity to RECCE®327, polyethylene glycol (PEG), or
excipients in the investigational gel.

- Recent treatment with any investigational compound or dosing in another
clinical trial within protocol-defined windows.

- History of or current medical condition which would preclude participation in
the judgment of the Principal Investigator and Sponsor Medical Monitor.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central Randomisation using Interactive Web Response System (IWRS)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified permuted block scheme
Baseline HbA1c category:
- 9.5% (significantly elevated)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2 / Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/10/2026

Actual

Date of last participant enrolment

Anticipated

1/10/2027

Actual

Date of last data collection

Anticipated

30/11/2027

Actual

Sample size

Target

208

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

WA,VIC

Recruitment hospital [1]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment hospital [2]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

3220 - Geelong

Recruitment postcode(s) [2]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Recce Pharmaceuticals Limited

Address [1]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Recce Pharmaceuticals Limited

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee A

Ethics committee address [1]

https://monashhealth.org/research/resources/resource-library/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/07/2026

Approval date [1]

18/08/2026

Ethics approval number [1]

RES-24-0000-292A

Summary

Brief summary

RECCE®327 topical gel has been developed through a stepwise clinical program from early
evaluation of safety, pharmacokinetics (PK), and preliminary efficacy to later-stage development in diabetic-related foot infection (DFI). Early clinical studies demonstrated minimal systemic absorption following topical administration, with systemic exposures substantially below those shown to be well tolerated following intravenous administration, supporting continued clinical development of RECCE®327 as a topical antibacterial therapy.
DFI has been selected as the primary target indication because of its significant unmet medical need and the potential advantages of achieving high local antimicrobial concentrations while minimizing systemic exposure. Part A of this study (ACTRN12624000973516) provided the safety, PK, and preliminary efficacy data that informed the design of Part B, a randomized, active-controlled study intended to generate comparative efficacy and safety data. Although conducted under a common protocol and governance framework, Parts A and B have separate objectives, study designs, and statistical analysis plans, and data from each part will be analysed and reported separately.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Eugene Athan

Address

Barwon Health, University Hospital Geelong, Ryrie St, Geelong, VIC 3220, Australia

Country

Australia

Phone

+61 342152878

Fax

[email protected]

Contact person for public queries

Name

Julie Charlton

Address

Recce Pharmaceuticals Limited, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102

Country

Australia

Phone

+61 893629860

Fax

[email protected]

Contact person for scientific queries

Name

juliE Anne Charlton

Address

Recce Pharmaceuticals, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102

Country

Australia

Phone

+61893629860

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically