Non-Invasive Assessment of Wound Healing With Optical Methods

Diabetic Foot Ulcers Clinical Trial

Official title:

Non-Invasive Assessment of Wound Healing With Optical Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578604
• Other study ID #: 17035
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: March 28, 2017
• Start date: September 2007
• Est. completion date: June 2014

Study information

• Verified date: March 2017
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer

Intervention

Device:
• diffuse near infrared spectroscopy measurements
Measure blood flow to diabetic wounds

Locations

Country	Name	City	State
United States	Drexel University College of Medicine Wound Care Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diffuse near infrared spectroscopy measurements	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.	3 years