A Novel Diagnostic Test for End-Stage Sensory Failure Associated With Diabetic Foot Ulceration: Proof-of-Principle Study

Abstract

Background: Diabetic foot ulceration (DFU) affects only a subgroup of patients with diabetic neuropathy, that is, those with pain-insensitivity due to end-stage sensory failure. Pain perception failure develops insidiously and remains asymptomatic until first DFU. As loss of pain perception is clinically significant, timely detection is mandatory. Objectives: A novel suprathreshold pinprick pain stimulus of 512 mN force made from optical glass-fiber was explored in a prospective cross-sectional diagnostic accuracy study to detect DFU-related end-stage sensory failure. Methods: A total of 116 participants were studied (25 healthy people, 22 patients with diabetes without relevant complications, 19 patients with previous painful foot or leg injuries, and 50 patients with previous or active painless DFU [reference standard]). Palmar and plantar surfaces were stimulated in a standardized fashion. At the feet, the second and third toe skinfolds and the middle of the plantar arch were stimulated. Participants scored stimulated pricking discomfort or pain intensity 0 to 10 on a numerical rating scale. Results: At hands, intensity was rated on average 5 (1-10) [median (range)] by 114/116 participants. Per foot, participants without DFU scored 5 (1-10), while those with DFU scored 0 (0-3) ( P < .0001). At plantar toe skinfolds, the absence of pinprick pain perception detected DFU-associated sensory failure with an accuracy of 99.5% (sensitivity 99.5%, specificity 99.4%, positive likelihood ratio 248, and negative likelihood ratio 0.005). Conclusion: In this pilot study, nociceptive stimulation of a plantar toe skinfold with a 512 mN optical glass-fiber pinprick accurately identified DFU-associated end-stage sensory failure.

Short‐term effect of dressing with Dermaheal ointment in the treatment of diabetic foot ulcer: A double‐blinded randomized controlled clinical trial

“…Patients expressed the severity of their pain by selecting a point on a continuous line with endpoints spanning from 0 to 10, where 0 denotes “not at all experienced” and 10 signifies “highly experienced”). The NPRS is a straightforward instrument, known for its ease of administration, and has demonstrated reliability and validity in various studies for assessing pain intensity associated with DFUs 25,26 . Building on a prior analysis, the total score of the NPRS was classified into categories: none (score: 0, 1), mild (score: 2, 3), moderate (score: 4, 5), severe (score: 6), and very severe (score: 7–10) 27 …”

“…The NPRS is a straightforward instrument, known for its ease of administration, and has demonstrated reliability and validity in various studies for assessing pain intensity associated with DFUs. 25 , 26 Building on a prior analysis, the total score of the NPRS was classified into categories: none (score: 0, 1), mild (score: 2, 3), moderate (score: 4, 5), severe (score: 6), and very severe (score: 7–10). 27 …”

Early Detection to Prevent Foot Ulceration among Type 2 Diabetes Mellitus Patient: A Multi-Intervention Review

“…8 Meanwhile, the use of the pinprick test as a method of early diagnosis of DFU is also considered good to do, because the procedure is simple and can identify the risk of DFU well. 9 Overall, conventional interventions have several advantages and disadvantages. Based on the level of accuracy, this intervention has the highest level of accuracy when compared to other types of examinations.…”

“…In addition, direct intervention using conventional tools in the form of footwear equipped with sensors, 8 and pin-prick tests are also used to perform early detection of DFU. 9 Several existing studies only discuss one model of early detection of DFU in DM patients, however, studies that describe various interventions that can be carried out for early detection in DM patients have not been found. Therefore, this systematic review aims to explain various digital and conventional-based early detection interventions along with their advantages and disadvantages that can be used to assess risk factors for DFU in DM patients.…”

Effect of Honey Dressing on Wound Healing among Patients with Diabetic Foot Ulcer at Al-Ahsa, Saudi Arabia

“…DFU is caused by poor glycaemic control, poor circulation in lower extremities, peripheral arterial disease (PAD) with sensory neuropathy, calluses, improper foot care and footwear, dry skin, and many others. It is associated with significant morbidity subsequently leading to disability due to lower limb amputation and even death in severe conditions if not treated on time 2 . Diabetic peripheral neuropathy (DPN) eventually affects approximately 50% of adults with DM during their lifetime 3 .…”