Tissue Perfusion and Blood Flow Monitoring Technology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Wounds and Injuries

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Standard Care Group

Subjects who will undergo only standard wound care management.

No interventions assigned to this group

Hyperbaric Oxygen Therapy Group

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No