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Non-Invasive Assessment of Wound Healing With Optical Methods

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00578604
First received: December 20, 2007
Last updated: March 28, 2017
Last verified: March 2017
  Purpose
The objective of this project is to further the development of a non-invasive optically based NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment optimization of chronic wounds (especially diabetic) in a clinical setting. The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel. Our animal studies have shown that the early healing of chronic wounds can be characterized by absorption and scattering of light at near infrared wavelengths ranging from 680 nm to 950 nm. If our project is successful we will be providing the clinician the ability to predict if a wound is healing and if a particular treatment is successful in accelerating healing before any changes are observed by wound size contraction or other visible clinical signs. Our hope is that the fNIR optical device will provide conclusive therapeutic treatment information as early as 5 weeks after initial evaluation, before it would be obvious on gross examination of the patient.

Condition Intervention
Diabetic Foot Ulcers Device: diffuse near infrared spectroscopy measurements

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Assessment of Wound Healing With Optical Methods

Resource links provided by NLM:


Further study details as provided by Drexel University ( Drexel University College of Medicine ):

Primary Outcome Measures:
  • diffuse near infrared spectroscopy measurements [ Time Frame: 3 years ]
    The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel and is comparable to SOC doppler.


Enrollment: 38
Study Start Date: September 2007
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with a diabetic wound
Patients with a diabetic wound
Device: diffuse near infrared spectroscopy measurements
Measure blood flow to diabetic wounds
Control
Patients without a diabetic wound
Device: diffuse near infrared spectroscopy measurements
Measure blood flow to diabetic wounds

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Recruited patients will be patients with diabetes who have chronic wounds and will likely have other co-morbidities associated with chronic diabetes.

Control subjects do not have diabetes and do not have wounds.

Criteria

Healthy Subject inclusion criteria

  • Subjects must be 18-65 years of age
  • Subjects must have no history of diabetes
  • Subjects must have no history of vascular disease
  • Subjects must have no findings of vascular disease on physical examination
  • Subjects who are not allergic to Tegaderm

Patient Subject inclusion criteria:

  • Subjects must be 18-65 years of age
  • Subjects must have documented diabetes mellitus for at least 6 months.
  • Subjects must have at least one documented chronic wound for a minimum 8 weeks.
  • A chronic wound is defined as any wound that has not healed after 8 weeks and has a minimum surface area of 1cm2. There is no maximum wound size.
  • Wound(s) must be secondary to the complications of diabetes, including vascular disease neuropathy, or both.
  • Wounds must be on the ankles or feet
  • Subjects who are not allergic to Tegaderm

EXCLUSION CRITERIA

  • Subject must not be <18 or >65 years of age
  • Subjects with major infections, abscesses, or untreated osteomyelitis will be excluded until appropriately treated.
  • Subjects will not be excluded based upon the existence of other co-morbidities associated with chronic diabetes, including retinopathy, nephropathy, peripheral neuropathy, or cardiovascular disease except as follows:
  • Subjects who have moderate to severe vascular insufficiency (defined as ankle brachial index <0.75 or toe-brachial index <0.5)
  • Subjects who are unable to return for weekly follow-up appointments will not be included.
  • Pregnant or lactating people will not be invited to participate.
  • Subjects who are allergic to Tegaderm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578604

Locations
United States, Pennsylvania
Drexel University College of Medicine Wound Care Center
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University College of Medicine
Investigators
Principal Investigator: Michael S Weingarten, M.D. Drexel University College of Medicine
  More Information

Responsible Party: Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00578604     History of Changes
Other Study ID Numbers: 17035
Study First Received: December 20, 2007
Last Updated: March 28, 2017

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases

ClinicalTrials.gov processed this record on September 21, 2017