EDX110 Randomized Control Trial for Treatment of DFUs

Conditions

• Diabetic Foot Ulcer
• Wound Heal

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• EDX110 — DEVICE
  EDX110 wound dressing system EDX110 is a dressing system comprising two layers that allows the generation of nitric oxide (NO) in situ, enables adequate moisture management and facilitates debridement

Study Details

Prospective, multi-centered, observer blinded, pre-market study, 1:1 randomized control trial, to determine if addition of EDX110 dressing system to standard of care leads to an improvement in diabetic foot ulcers healing compared to just using standard of care.

Key Dates

Start date

Oct 30, 2025

Status verified

Dec 2025

Primary completion

Dec 1, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

298 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: EDX110 with Standard of Care (SOC)
  Diabetic Foot Ulcer (DFU) DFU treatment with EDX110 wound dressing and SOC
• No Intervention: Standard of Care (SOC)
  Diabetic Foot Ulcer (DFU) DFU treatment with using only traditional Standard of Care (SOC)

Primary Outcome Measure

Wound Closure [ Time Frame: 16 Weeks ]

Central Contacts

• Andrea M Picchietti
  2604189196
  [email protected]
• Christina Mastandrea
  5088739580
  [email protected]

Locations (4)

Find similar trials in Phoenix, AZ

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