Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

CW Optics

Status: Completed

Conditions: Wounds and Injuries

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01675583

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

WoundImager-2012-01

Details and patient eligibility

About

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

Enrollment: 20 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:

  • Necrotizing fasciitis
  • Compromised/failed skin grafts/flaps
  • Chronic refractory osteomyelitis
  • Soft tissue radiation necrosis
  • Diabetic wounds, lower extremity
  • Acute peripheral arterial insufficiency
  • Crush injury
  • Venous leg disease
  • Pressure ulcer
  • Other chronic, non-healing wounds

• Subjects must have signed the Informed Consent Forms.

Exclusion Criteria

• 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

20 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.