Diabetes, Foot Ulcer
Conditions
Brief summary
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.
Interventions
DEVICEKC-002
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.
Normal Saline Dressings
Sponsors
KeraCure
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment | 12 weeks |
Countries
United States
Contacts
Primary ContactM Meek
Outcome results
None listed