A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
Not Applicable
Terminated
- Conditions
- Diabetic Foot Ulcers
- Interventions
- Device: Powered Suction PumpDevice: Powered Suction Pump (VAC Freedom)Device: MWT
- Registration Number
- NCT00605189
- Lead Sponsor
- KCI USA, Inc
- Brief Summary
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Type II diabetes
- Subject has a diabetic foot ulcer 5cm squared or greater
- Subject's diabetic foot ulcer is chronic
Exclusion Criteria
- HgbA1c of 12% or greater
- Presence of cellulitis
- Presence of osteomyelitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gauze-Based NPWT Powered Suction Pump - VAC NPWT Powered Suction Pump (VAC Freedom) - Moist Wound Therapy MWT -
- Primary Outcome Measures
Name Time Method Compare Energy Charge Between Wound Treatment Therapies Day 0, Day 2, Day 7 Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit.
Energy Charge is calculated as follows:
Energy Charge = (ATP + (0.5 \* ADP)) / (ATP + ADP + AMP)
Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Texas Health Science Center San Antonio
🇺🇸San Antonio, Texas, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States