Tissue Perfusion and Blood Flow Monitoring Technology

NCT01139567 | Completed

• 2 other identifiers: WoundImager-2010-015R44HL059807-06
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wounds and Injuries

Keywords

Diabetic Wounds; Hyperbaric Oxygen; Laser Speckle Imaging; Hyperbaric Oxygenation

Outcome Measures

Primary Outcomes (1)

• Effectiveness of blood flow velocity measurements of wound sites to assess tissue viability with a novel optical device. Comparison between the responses of patients treated with hyperbaric oxygen therapy and those treated by other means will be made.

  2 years

Study Arms (2)

Standard Care Group

Subjects who will undergo only standard wound care management.

Hyperbaric Oxygen Therapy Group

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who have chronic lower extremity wounds will be recruited from the patient population at the Chippenham and Johnston-Willis Medical Center (CJW) for enrollment in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CW Optics, Inc.: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Chippenham and Johnston-Willis Medical Center

Richmond, Virginia, 23225, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: June 8, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 2, 2013

Record last verified: 2013-06

Locations

US (1)