CompletedPhase 1/2

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

Israel20 participantsStarted 2021-03-22

Plain-language summary

This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. At least 1 year post-menopausal (amenorrhea \>12 months prior to screening);
✓. Surgically sterile (bilateral oophorectomy or hysterectomy);
✓. If of childbearing potential, must agree to use a highly effective method of birth control from screening until 14 days after the last administration of IP.

What they're measuring

1. Incidence and severity of treatment-emergent solicited local and systemic AEs and relationship to IP from first administration until 1 week after end of treatment (EOT) (end of study -EOS)

Timeframe: 1 week

2. Incidence and severity of treatment-emergent unsolicited AEs and relationship to IP from first administration until EOS.

Timeframe: 1 week

3. Incidence and severity of treatment-emergent SAEs and relationship to IP from first administration until EOS.

Timeframe: 1 week

Trial details

NCT IDNCT04803708

SponsorTechnophage, SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-07

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials