Case Studies « HyperMed, Inc.

Case Study – Diabetic Foot Ulcer
Case Study – Diabetic Ulcer Healing
Case Study – Diabetic Ulcer Prediction
Case Study – Claudication
Case Study – Acute Ischemia (Cuff Ischemia)

Case Study – Diabetic Foot Ulcer

This 52 year old patient with a long standing history of type 1 diabetes and recurrent ulcers bilaterally presented at his first study visit with an ulcer on each foot. This figure shows two visits separated by 6 weeks. At his first visit, the subject had one ulcer on the big toe of the left foot and one ulcer on the 2nd MTPJ of the right foot. The elevated HT measurements on the left big toe predicted that the ulcer would heal and the low HT measurements on the right foot predicted that the ulcer would not heal. On return 6 weeks later, these predictions were seen to be correct, with areas that HT indicated would heal having healed, areas predicted not to heal, not having healed and areas indicated to be at risk becoming involved in ulcer spread. Of note, this subject’s entire right foot deteriorated substantially between visits, with not only spreading of the ulcer, but also a generalized decrease of both HT-Oxy and HT-Deoxy parameters. Note new sharp edges of the wound after debridement. This debridement may have contributed to the further deterioration of the right foot. This subject subsequently had a right below the knee amputation.

Case Study – Diabetic Ulcer Healing

The color bar can be used to quickly identify different regions of tissue oxygenation that then can be quantified by using the HyperVu software. HT-oxy levels are related to color changes (low to high, yellow to purple) – HT-deoxy levels are related to brightness (low to high, pale to brilliant).

This 43 year old Indian female with type I diabetes with an ulcer of the sub hallux interphalangeal joint of the right foot was followed for 1 year. She also had diagnoses of hyperlipidemia, hypertension, hypothyroidism and peripheral neuropathy. She had been admitted two months previously for acute cellulitis of the right foot and diagnosed with osteomyelitis of the right hallux distal and proximal phallanx by MRI and bone scan. She had been treated with IV ertapenem for 6 weeks followed by oral antibiotics. The ulcer can be seen to be largely healed one month later.

A positive HTcOM Healing Index around the ulcer at the first visit was consistent with healing wounds and would support continued conservative therapy. In other subjects, a negative HTcOM Healing Index was associated with non-healing and would support a more aggressive approach including offloading, hyperbaric therapy, or angiography and revascularization.

Case Study – Diabetic Ulcer Prediction

This 68 year old Hispanic female with type 1 diabetes had an ulcer on her right heal and was considered at high risk for additional ulceration. Over 2 months, she developed 2 new ulcers, one on each foot. In each case, tissue at risk was identified by HTcOM. The left foot ulcer & data from the two preceding visits is shown above. Areas of lower oxygenation on the HTcOM-Oxy and HTcOM-Deoxy color scale correlate with areas that proceeded to ulceration on both feet. Note that on the color photo, the skin tissue appears normal at the week 4 visit, minimally discolored but with intact skin at the week 6 visit, and newly ulcerated at the week 8 visit.

An HT-Ulcer Prediction Index was created from the HT-Oxy and HT-Deoxy values for each point. The HT- Ulcer Prediction Index indicates the likelihood of ulceration with negative values (see above).

A preliminary HT-Oxy Ulcer Prediction Ratio was also created by comparing the HT-Oxy within a pre-ulcer area with the HT-Oxy from a nearby site. Here, a value less than 0.75 is associated with pre-ulcer regions as shown above.

An additional area on the plantar skin surface over the first metatarsal is considered at high risk. This will be followed in the additional 8 study visits.

Further algorithm development is underway. The trial design anticipates the occurrence of at least 20 new ulcers over the course of the study, which will provide sufficient power for appropriate statistical analysis of the accuracy of the HT- Ulcer Prediction Index and an HT – Ulcer Prediction Ratio. Note, the 3rd HT scan above was performed on new hardware & values were corrected with a scalar.

Case Study – Claudication

HT study of a mild/moderate claudicator with pain while functioning as a facilities maintenance man during his work day. Angiography showed evidence of L common femoral artery occlusion. Long segment occlusion precluded successful angioplasty/stent at the Lahey Clinic. The study showed reconstitution before the SFA/profunda bifurcation with good distal runoff. The top row demonstrates changes due to vascular compromise seen at baseline, including an “island of ischemia” in the center of the forefoot. Before we started the study the subject pointed to this region as the place that had dysesthesias long before claudication started.

The bottom row shows dramatic changes after brief exercise (until pain occurred while he was carrying a box and walking briskly for 1 minute, which is typical of his work requirements).

Key points:

Study displays a good example of early skin changes associated with islands of ischemia
Post exercise study demonstrates changes associated with vascular (common femoral) occlusion
Post exercise study demonstrates changes associated with minor (50% common femoral) obstruction
Study demonstrates changes associated with superficial ulceration

Case Study – Acute Ischemia (Cuff Ischemia)