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# Guidance on Diabetic Foot Infection Drugs
- URL: https://www.fdaweb.com/guidance-on-diabetic-foot-infection-drugs/
- Published: 2023-10-16T12:00:00.000Z
- Updated: 2026-09-14T14:13:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155565

FDA has released a [draft guidance](https://www.fda.gov/media/173006/download?ref=fdaweb.com) entitled “Diabetic Foot Infections: Developing Drugs for Treatment.” The document is intended to assist developers that are developing such drugs where concomitant bone and joint issues are not involved. It provides FDA’s current thinking regarding the overall development program and clinical trial designs for such drugs.

The guidance says that in assessing antibacterial drug efficacy for treating diabetic foot infections (DFI), sponsors should consider providing Phase 1 data demonstrating adequate drug penetration into the outer skin layers. “We recommend sponsors discuss with the agency the type of technique to evaluate drug penetration before study initiation,” it says.

Regarding the drug development population, developers should include subjects with diabetes mellitus who have a bacterial infection of the foot, located at or distal to the malleoli, according to the guidance. “The use of a classification system characterizing the extent of the lesion and systemic signs and symptoms may be considered to define the study population,” it says.

Additionally, the guidance says noninferiority trials are acceptable to support a drug’s approval for DFI as long as an acceptable noninferiority margin is clearly justifiable. “Superiority trials comparing the investigational drug to an active control are also readily interpretable and provide direct evidence of treatment benefit,” it says. While two adequate and well-controlled trials are generally recommended to support approval, a single adequate and well-controlled trial “supported by other independent confirmatory evidence, such as a trial in another related infectious disease indication (e.g., acute bacterial skin and skin structure infections), can potentially provide evidence of effectiveness in support of an indication for the treatment of DFI,” it says. However, sponsors are recommended to discuss with the agency the confirmatory evidence that could support findings from a single trial.