Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers (KC-002PT)

KeraCure

Status and phase: Unknown; Phase 2

Conditions: Diabetes; Foot Ulcer

Treatments: Device: KC-002; Other: Conventional Wound Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00330265

NCT 20051320

Details and patient eligibility

About

The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.

This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study.

Participation in the study is for 24 weeks.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants included in the study must:

• Have Type 1 or Type 2 diabetes mellitus
• Have a diabetic foot ulcer on the bottom of the foot or heal which has been present for three (3) weeks but less than two (2) years and is sufficient size to qualify for the study
• Be able to visit the study doctor regularly for 24 weeks

Exclusion criteria

Participants may not be included if:

• The diabetic foot ulcer is infected
• They have poor circulation in their study foot
• Cannot or will not wear a special boot to take pressure off the study ulcer
• They have certain other diseases or laboratory values which are not within a specified range

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1

Experimental group

Description:

KC-002

Treatment:

Device: KC-002

2

Other group

Description:

Conventional Wound Therapy

Treatment:

Other: Conventional Wound Therapy