Hyperspectral Technology and Changes in Diabetic Foot Ulcers

NewsBot · Feb 17, 2007

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The Use of Medical Hyperspectral Technology to Evaluate Microcirculatory Changes in Diabetic Foot Ulcers and Predict Clinical Outcomes.
Diabetes Care. 2007 Feb 15;
Khaodhiar L, Dinh T, Schomacker KT, Panasyuk SV, Freeman JE, Lew R, Vo T, Panasyuk AA, Lima C, Giurini JM, Lyons TE, Veves A

Background: Foot ulceration (DFU) is a serious complication of diabetes and new techniques that can predict wound healing may prove very helpful. We tested the ability of Medical Hyperspectral Technology (HT), a novel diagnostic scanning technique which can quantify tissue oxy- and deoxyhemoglobin, to predict DFU healing.

Methods: Ten T1DM patients with 21 foot ulcer sites, 13 T1DM without ulcers and 14 non-diabetic controls were seen up to four times over a 6-month period. HT measurements of oxyhemoglobin (HT-Oxy), deoxyhemoglobin (HT-Deoxy) were performed at or near the ulcer area, and on the upper extremity and the lower extremity distant from the ulcer. A HT-Healing Index for each site was calculated from the HT-Oxy and HT-Deoxy values.

Results: Hyperspectral tissue oxygenation measurements observed changes in tissue immediately surrounding the ulcer when comparing ulcers that heal and ulcers that do not heal (p <.001). The sensitivity, specificity, positive predictive and negative predictive value of the HT Index to predicting healing were 93%, 86%, 93% and 86% when evaluated on images taken at the first visit. Changes in HT-Oxy among the three risk group were noted for the metatarsal area of the foot (p <.05) and the palm (p <.01). Changes in HT-Deoxy and HT Healing Index were noted for the palm only (p <.05 and p <.01, respectively).

Conclusions: HT has the capability to identify microvascular abnormalities and tissue oxygenation in the diabetic foot and predict ulcer healing. HT can assist in the management of foot ulceration.
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Admin2 · Feb 17, 2007

Re: Hyperspectral Technology and Changes in Diabetic Foot Ulcer

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NewsBot · Jul 20, 2008

New Technology Predicts Healing Potential of Diabetic Ulcers

Press Release:
New Technology Predicts Healing Potential of Diabetic Ulcers
Diabetic wound indicator could significantly reduce diabetic amputation rates

New research technology, named Hyperspectral Transcutaneous Oxygen Montitoring (HTcOM), effectively measures real-time oxygen levels surrounding the foot ulcerations commonly seen in patients with type 1 and 2 diabetes. The measurements taken with HTcOM are calculated in approximately 15 seconds, and can then be used to determine the most successful treatment plan for that particular wound. Two poster abstracts summarizing results from the study will be presented at the American Podiatric Medical Association’s (APMA) 96th Annual Scientific Meeting in Honolulu from July 24-27.

"Hyperspectral imaging will quickly become one of the most important tools physicians can use to assist diabetic patients in wound care treatment," said Aksone Nouvong, DPM, a podiatric physician involved in the study and an assistant clinical professor at UCLA’s David Geffen School of Medicine. "One of the most important findings we have discovered while studying HTcOM is that if a patient already has an existing foot wound, this technology can tell right away whether or not the ulcer has the ability to heal on its own."

Study data on HTcOM was collected in a Phase 2 longitudinal study at the National Institutes of Health (NIH), and looked at 66 type 1 and 2 diabetic subjects with at least one foot ulcer. Over six months, HTcOM was used to monitor oxygen levels at the site of the various ulcerations and accurately predicted which ulcer would heal. Interim data of 28 subjects that had completed the study after six months showed that 29 of the 36 ulcers had displayed positive healing potential after being treated based on HTcOM measurements. The positive predictive value for healing was 100 percent with this interim data cut.

According to Dr. Nouvong, the technology may begin to make its way into physicians' offices across the country after the full set of research data on HTcOM is released in September.

"Many lower-limb amputations currently being performed have to be done at an unnecessarily high level – often because the physician has no way of knowing the exact spot at which to perform an effective amputation," Dr. Nouvong said. "A patient who might have had an entire foot amputated may be found to only need to have their big toe done after being assessed with HTcOM."
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NewsBot · Jul 20, 2008

Re: New Technology Predicts Healing Potential of Diabetic Ulcers

Attached is the abstract from the above researech.

NewsBot · Jul 31, 2009

EVALUATION OF DIABETIC FOOT ULCER HEALING WITH HYPERSPECTRAL IMAGING OF OXYHEMOGLOBIN AND DEOXYHEMOGLOBIN.
Nouvong A, Hoogwerf B, Mohler E, Davis B, Tajaddini A, Medenilla E.
Diabetes Care. 2009 Jul 29. [Epub ahead of print]

Objective- Foot ulceration remains a major health problem for diabetic patients and has a major impact on cost of diabetes treatment. We tested a hyperspectral imaging technology that quantifies cutaneous tissue hemoglobin oxygenation and generated anatomically relevant tissue oxygenation maps to assess the healing potential of diabetic foot ulcers (DFU).

Research Design and Methods- Prospective single arm blinded study that enrolled 66 patients with type 1 and 2 diabetes mellitus (DM) and followed them over a 24-week period. Clinical, medical and diabetes histories were collected. Transcutaneous oxygen tension was measured at the ankles. Superficial tissue oxyhemoglobin and deoxyhemoglobin were measured with hyperspectral imaging from intact tissue bordering the ulcer. A healing index, derived from oxyhemoglobin and deoxyhemoglobin values was used to assess the potential for healing.

Results- Fifty-four patients with 73 ulcers completed the study; 54 ulcers healed while 19 ulcers did not heal at 24 weeks. When using the healing index to predict healing, the sensitivity was 80% (43/54), the specificity was 74% (14/19), and the positive predictive value was 90% (43/48). The sensitivity, specificity and positive predictive values increase to 86%, 88% and 96% respectively, when removing three false positive osteomyelitis cases and four false negative cases due to measurements on a callus. The results indicate that cutaneous tissue oxygenation correlate with wound healing in DM patients.

Conclusion- Hyperspectral imaging of tissue oxyhemoglobin and deoxyhemoglobin may predict healing of DFUs with high sensitivity and specificity based on information obtained from a single visit.
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NewsBot · Oct 6, 2010

Hyperspectral imaging in diabetic foot wound care.
Yudovsky D, Nouvong A, Pilon L.
J Diabetes Sci Technol. 2010 Sep 1;4(5):1099-113.

Diabetic foot ulceration is a major complication of diabetes and afflicts as many as 15 to 25% of type 1 and 2 diabetes patients during their lifetime. If untreated, diabetic foot ulcers may become infected and require total or partial amputation of the affected limb. Early identification of tissue at risk of ulcerating could enable proper preventive care, thereby reducing the incidence of foot ulceration. Furthermore, noninvasive assessment of tissue viability around already formed ulcers could inform the diabetes caregiver about the severity of the wound and help assess the need for amputation. This article reviews how hyperspectral imaging between 450 and 700 nm can be used to assess the risk of diabetic foot ulcer development and to predict the likelihood of healing noninvasively. Two methods are described to analyze the in vivo hyperspectral measurements. The first method is based on the modified Beer-Lambert law and produces a map of oxyhemoglobin and deoxyhemoglobin concentrations in the dermis of the foot. The second is based on a two-layer optical model of skin and can retrieve not only oxyhemoglobin and deoxyhemoglobin concentrations but also epidermal thickness and melanin concentration along with skin scattering properties. It can detect changes in the diabetic foot and help predict and understand ulceration mechanisms.
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NewsBot · Mar 13, 2019

This patent was just granted:
HYPERSPECTRAL TECHNOLOGY FOR
ASSESSING AND TREATING DIABETIC
FOOT AND TISSUE DISEASE

This invention relates generally to an index map comprising both pressure and perfusion information from a diabetic
patient foot for the purpose of treatment . The index map may also be a map of perfusion and / or metabolism of the tissue
( reflecting oxygen delivery and oxygen extraction , obtained
by thermal imaging , hyperspectral imaging , or duplex ultra
sound , MRA , CT or laser Doppler imaging . This informa
tion aids treatment in prevention of diabetic foot ulceration
and amputation and in treatment of tissue compromise to
prevent tissue loss in other body regions .
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Link to patent

NewsBot · Jan 16, 2023

Use of Hyperspectral Imaging to Predict Healing of Diabetic Foot Ulceration
Konstantinos Kounas et al
Wound Repair Regen. 2023 Jan 12

Our main objective was to validate that hyperspectral imaging via a new portable camera carries the potential to provide a reliable clinical biomarker that can predict DFU healing. We recruited patients with diabetic foot ulceration (DFU) without peripheral arterial disease, infection or other serious illness. Using an hyperspectral imaging (HSI) apparatus, post-debridement hyperspectral images were taken evaluating the ulcer size, periwound oxyhemoglobin (OxyHb), deoxyhemoglobin level (DeoxyHb) and oxygen saturation (O2 Sat) for four consecutive visits. Twenty-seven patients were followed, out of whom seven healed their DFU while the remaining 20 failed to heal their DFU. The average time between each visit was three weeks. Binary logistic regression of healers vs non-healers on Visit 1 oxyHb and on Visit 2 showed a significant inverse association, OR = 0.85 (95% CI 0.73 - 0.98, P <0.001). An inverse correlation was observed between the Visit 1 oxyHb and the percentage of ulcer size reduction between Visit 1 and the Visit 4 (r = -0.46, p=0.02) and between the Visit 2 oxyHb and the percentage of ulcer size reduction between Visits 2 and 4 (r = -0.65, p=0.001). Using oxyHb 50 as the cutof point to predict DFU complete healing, Visit 1 oxyHb measurement provided 85% sensitivity, 70% specificity, 50% positive predictive value and 93% negative predictive value. For Visit 2, oxyHb had 85% sensitivity, 85% specificity, 66% positive predictive value and 94% negative predictive value. We conclude that this preliminary study, which involved a relatively small number of patients, indicates that hyperspectral imaging is a simple exam that can easily be added to daily clinical practice and has the potential to provide useful information regarding the healing potential of DFU over a short period of time.
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