A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

KCI USA, Inc

Status: Terminated

Conditions: Diabetic Foot Ulcers

Treatments: Device: Powered Suction Pump (VAC Freedom); Device: Powered Suction Pump; Device: MWT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605189

VACP2005-009

Details and patient eligibility

About

A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

VAC NPWT

Active Comparator group

Treatment:

Device: Powered Suction Pump (VAC Freedom)

Gauze-Based NPWT

Active Comparator group

Treatment:

Device: Powered Suction Pump

Moist Wound Therapy

Active Comparator group

Treatment:

Device: MWT