Tissue Perfusion and Blood Flow Monitoring Technology (WoundImager)

CW Optics

Status: Completed

Conditions: Wounds and Injuries

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01139567

5R44HL059807-06 (U.S. NIH Grant/Contract)

WoundImager-2010-01

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. The hypothesis is that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.

Enrollment: 56 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements:

  • neuropathic diabetic foot ulcer
  • soft tissue radiation necrosis
  • crush injury
  • compromised/failed skin grafts and flaps

• Subjects must have signed the Informed Consent Forms.

Exclusion Criteria

• Subjects who are not candidates for HBO therapy for any reason, including but not limited to: untreated pneumothorax, uncontrolled congestive heart failure, seizure disorder, neoplastic tumors, claustrophobia (for those in the HBO Group).
• Female subjects who are pregnant or nursing.
• Anyone who is unable to give written informed consent.
• Subjects with end-stage renal disease or who require peritoneal or hemodialysis.
• Subjects with current malignancies.

Trial design

56 participants in 2 patient groups

Standard Care Group

Description:

Subjects who will undergo only standard wound care management.

Hyperbaric Oxygen Therapy Group

Description:

Subjects who are selected for adjunctive hyperbaric oxygen therapy in addition to standard wound care intervention.