New Dressing for Diabetic Foot Ulcers

A Phased Validation Trial of an Investigational Dressing Material in the treatment of Diabetic Foot Ulcers - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107707

Enrollment

Registered

2026-04-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E134- Other specified diabetes mellituswith neurological complications

Interventions

Intervention1: Phoenix-Aid Shield Wound Dressing Manufactured in USA by Phoenix-Aid Inc.: Participants will receive the investigational dressing as the primary dressing. This Wound dressing material

Eligibility

Inclusion criteria

Inclusion criteria: Individuals with diabetic foot ulcers (1 20 cm ), uninfected or mildly infected, including Grade I soft-tissue infections and suitable post-operative wounds for outpatient care. Subjects must have HbA1c less than or equal to 12 percent and ABI greater than or equal to 0.8. Participants should be able to provide informed consent.

Exclusion criteria

Exclusion criteria: -Critical limb ischemia or imminent need for revascularization -Clinical or radiological evidence of osteomyelitis in the index limb. -Patients with Grade II (moderate) or Grade III (severe) soft-tissue infections, as per IDSA classification. -Necrotizing infection or gangrene of the index limb -Laboratory values at screening Hb less than 8 percent e-GFR less than 30mL/min/1.73m -Known allergy to dressing components -Malignancy within the wound or suspected cancer at the ulcer site. -Patients with history of HIV -Patients currently receiving VAC (Negative Pressure Wound Therapy) or Hyperbaric Oxygen Therapy (HBOT) for ulcer management will be excluded from the study -Use of another investigational device or drug within 30 days prior to screening -Pregnancy and Lactation -Any medical or psychiatric condition that would interfere with participation or wound assessment as judged by the investigator

Design outcomes

Primary

Measure	Time frame
Faster healing wounds with non bulky material which can accommodate an offloading foot wear. Reduction in wound size and infection control with better compliance. Timepoint: 98 days	—

Secondary

Measure	Time frame
Efficacy of Home care dressing kit to reduce Hospital stay as a cost effective measure. Timepoint: 98 days	—

Countries

India

Contacts

Public ContactDr Satyavani Kumpatla

M V Hospital for Diabetes and Prof M Viswanathan Diabetes Research Centre

senaakee@gmail.com9840067251

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026