Over 37 million Americans have diabetes, with 1.4 million newly diagnosed each year. In addition, the illness is growing quickly worldwide and has many associated complications, including cardiovascular disease, nerve damage, neuropathy, kidney damage, and diabetic foot ulcers (DFUs). Patients with DFUs are at high risk for amputations that can result in permanent loss of mobility and earning power – yet 75% of DFUs are preventable! Our VP of Clinical Affairs writes about how Spectral AI’s developing AI technology for wound healing can help.
With millions of Americans already diagnosed with diabetes, and millions more to come in the U.S. and (increasingly) around the world, there is still no diagnostic tool that objectively assesses a patient’s status and predicts the future course of their diabetic foot ulcers. Instead, healthcare professionals continue to rely on subjective assessments – better known as guesswork — to determine if diabetic foot ulcers will worsen or respond to treatment. Because the first Diabetic Foot Ulcer amputation often leads to a second. Alarmingly, 85% of amputations are preceded by a DFU. The average life expectancy after a DFU is 5 years. DFU should be viewed as a life-threatening condition deserving of specialized care.
The costs of uncertainty in diabetic foot ulcer assessment and treatment
The current state of care has significant costs – in patient suffering, healthcare costs, and worker productivity. Patients suffer needlessly because currently DFU care isn’t generally provided by specialists in wound healing. In addition, most community hospitals or even larger centers do not have a standardized DFU workup protocol, defined criteria for specialist referral, or specialized multidisciplinary teams. This can result in unnecessary admissions, delay of care, prolonged hospitalization, and inappropriate management of diabetic foot ulcer disease. Ensuring that patients receive the correct care in a timely manner is imperative to patients outcomes. A thorough understanding of the causes, management and treatment of diabetic foot ulceration is essential to reducing lower-extremity amputation risk. Lastly preventing the delay in expert DFU care can get patients back in motion to their lives and reduce the lost patient productivity totaling some $90 billion a year.
The diagnostic future for diabetic foot ulcers is now
Despite these hurdles, with proper assessment and treatment 75% of DFUs are treatable and can be prevented. Spectral AI is developing a wound assessment tool enhanced with artificial intelligence (AI) that promises to be the long-awaited game-changer for managing DFUs. Our DeepView® technology is a diagnostic platform that combines AI algorithms with medical imaging for wound healing predictions.
DeepView® proprietary imaging system can extract millions of multispectral data points from each raw wound image. DeepView® AI utilizes the multispectral images to determine if a DFU will close by 50 percent in four weeks with an 86 percent accuracy DeepView® provides accurate, objective predictions of wound healing at the time of the patient’s evaluation of their DFU. DeepView can help clinicians determine if expert wound care should be incorporated into the patient’s care plan without delay.
A wound assessment tool that uses artificial intelligence (AI) will be the long-awaited game-changer for managing DFUs.
Spectral AI: A new future for diabetic foot ulcer evaluation
By enabling clinicians to immediately and objectively assess wounds, our DeepView® technology holds the promise of reducing the suffering and uncertainty DFU patients worldwide typically endure. To learn more about Spectral AI and DeepView®, please contact Spectral AI. We’re eager to demonstrate the possibilities.
Mary Regan, Ph.D., serves as VP Clinical Affairs at Spectral AI, where she oversees all clinical trials and supports the commercial business operations. Dr. Regan brings over 30 years of clinical experience in wound technology assessment, development, research, and innovation with major industry leaders. Widely renowned in national and international forums as an industry thought leader in wound care, Dr. Regan’s career has been dedicated to improving prevention and management of chronic wounds and clinical research to improve outcomes for all patients with wounds. Dr. Regan has held board positions in the American Association of Wound Care Specialists and National Wound Healing Society. Dr. Regan received her M.S./B.S. degrees in Registered Nursing, Nursing Administration, Nursing Research, and Clinical Nursing from SUNY Upstate Medical University and her Ph.D. in Nursing Science from the University of Miami.
Current methodologies for the assessment of diabetic foot ulcers involve a comprehensive evaluation of the patient’s medical history, physical examination, and, when necessary, diagnostic tests. A thorough medical history should encompass the duration and control of diabetes mellitus, previous foot ulcers or amputations, peripheral vascular disease, neuropathy, and any other relevant comorbidities or conditions.
The physical examination of the diabetic patient should focus on assessing the skin for signs of infection in the wound, ischemia, and neuropathy, as well as evaluating the presence of calluses, deformities, and the vascular status of the lower extremities. Furthermore, the assessment should include monofilament testing, ankle-brachial index measurement, and when indicated, vascular imaging studies such as Doppler ultrasound or angiography. Timely and meticulous assessment for diabetic foot ulcers is imperative to prevent wound complications and improve patient outcomes.
Performing a diabetic foot assessment is a critical aspect of managing diabetes, as individuals with diabetes are at increased risk of foot complications due to neuropathy, poor circulation, and other factors. A thorough assessment involves the identification of risk factors. Here is how to conduct a diabetic foot exam and diabetes assessment:
Gather information about the patient’s medical history, including duration of diabetes, blood sugar control and treatment methods, previous foot issues, and any existing complications.
Test for peripheral neuropathy using a monofilament, tuning fork, or other sensory tests. Evaluate the patient’s ability to feel sensations in various areas of the foot.
Assess arterial blood flow by examining pulses in the feet, including the dorsalis pedis and posterior tibial pulses. Absent or weak pulses may indicate poor circulation. Observe for signs of peripheral artery disease (PAD), such as coolness, pallor, or hair loss on the feet.
Inspect the skin for any signs of injury, infections, or ulceration. Pay particular attention to areas of calluses, corns, or blisters. Check for fungal infections, ingrown toenails, and other nail abnormalities.
Evaluate the structure and alignment of the feet, looking for deformities such as hammertoes or Charcot foot.
Review the patient’s footwear for proper fit, support, and signs of wear. Encourage the use of well-fitted, supportive shoes to prevent foot injury.
Document findings, interventions, treatment recommendations and patient education about diabetes in the medical record according to institutional protocols and standards.
Schedule regular diabetic foot assessments as part of the patient’s ongoing care plan, adjusting interventions as needed based on changes in the patient’s diabetes or other conditions. Collaborate with other healthcare providers to ensure comprehensive diabetes care and evaluation.
A basic foot assessment checklist for diabetic foot ulcer assessment typically includes the following components:
Peripheral vascular disease or circulation problems
Smoking history
Any recent trauma or injury to the feet
Visual Inspection:
Inspect the foot for any signs of ulceration, including redness, swelling, warmth, or drainage.
Look for calluses, corns, blisters, or other areas of abnormal skin integrity.
Check for signs of infection, such as pus, foul odor, or spreading erythema.
Location and Size of Ulcers:
Document the specific location of the foot ulcers (e.g., plantar surface, dorsum of the foot, between toes).
Measure the size of the foot ulcers using a ruler or specialized measuring tool.
Note any undermining or tunneling beneath the wound edges of the ulcers.
Depth of Ulcers:
Assess the depth of the ulcers by gently probing with a sterile probe or cotton-tipped applicator.
Determine if the ulcers involve superficial layers of the skin (partial thickness) or deeper tissues (full thickness).
Surrounding Tissue Assessment:
Evaluate the condition of the skin surrounding the ulcer for signs of maceration, ecchymosis, or hyperkeratosis.
Palpate for signs of warmth, induration, or fluctuance indicating infection or inflammation.
Periwound Assessment:
Examine the peri-ulcer skin for signs of moisture, edema, or dermatitis.
Note any evidence of poor perfusion or compromised tissue viability in the surrounding area.
Vascular Assessment:
Assess pedal pulses, including dorsalis pedis and posterior tibial pulses.
Perform a capillary refill test and assess skin temperature to evaluate peripheral circulation.
Look for signs of peripheral arterial disease (PAD), such as diminished or absent pulses, cool extremities, or hair loss on the toes.
Neurological Assessment:
Test sensation using a monofilament, tuning fork, or other sensory tests to assess peripheral neuropathy.
Evaluate proprioception and deep tendon reflexes in the lower extremities.
Functional Assessment:
Assess the patient’s mobility and ability to bear weight on the affected foot.
Consider factors such as gait abnormalities, balance issues, and functional limitations.
Documentation and Treatment Plan:
Document findings, including ulcer characteristics, measurements, and associated assessments.
Develop a comprehensive diabetic and wound treatment plan tailored to the patient’s specific needs, including wound care, offloading strategies, infection management, and patient education.
The possible infection of a diabetic foot ulcer can be indicated by various assessment data, including physical and laboratory findings. Physical features such as erythema, purulent discharge, malodor, and signs of cellulitis suggest the presence of infection. Additionally, laboratory investigations commonly done during the evaluation of the foot ulcers include a complete blood count, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP), which can indicate the presence of an infection. Moreover, the presence of specific bacteria such as Staphylococcus aureus, Streptococcus, and Pseudomonas aeruginosa in culture specimens taken from the ulcer can also suggest an infection.
The stages of diabetic foot ulcers are commonly classified into five categories, as described by the 7th Practical Diabetes International Foot Conference and the Wagner ulcer classification system. These stages are:
Stage 1 – Normal foot with no risk factors
Stage 2 – High-risk foot
Stage 3 – Ulcerated foot
Stage 4 – Cellulitic foot
Stage 5 – Necrotic foot
The development of a foot ulcer is a significant event in stage 3 and requires urgent and aggressive treatment. Proper management of diabetic foot care across all stages requires a multidisciplinary approach to address various aspects such as mechanical, wound, microbiological, vascular, metabolic, and educational factors 1,2.
There is no specific medical device tool for diabetic foot ulcers; however, there are guides to properly assess. The assessment tools for diabetic foot ulcer assessment include various scales and scoring systems. Some of the commonly used tools are:
DFUAS (Diabetic Foot Ulcer Assessment Scale)
DMIST (Deep, Maceration, Infection, Size, and Tunneling)
Each tool has its own limitations. For example, the DFUAS may have limited sensitivity and specificity for certain aspects of ulcer assessment, while the DMIST may not fully capture the complexity of certain ulcers. Additionally, the MUNGS tool may have challenges in standardization and practical application. It is important for healthcare professionals to consider the specific context and characteristics of the ulcer when selecting and using these assessment tools 3,4,5.
