Related studies
Relevant studies, to gain insights about diabetic sensorimotor polyneuropathy (DSPN): rates of unawareness, underdiagnosis, and undertreatment or expert recommendations to screening and management of DSPN.
PREDIP Registry Study
PREDIP is a prospective registry collecting routine clinical data on the burden, diagnosis and management of DSPN in Germany providing real-world insights.
Participants with DSPN (n=617) were recruited from practices or clinics and were classified by the intensity of neuropathic pain into severe/moderate painful DSPN (n=262), mild painful DSPN (n=210), and painless DSPN (n=145).1
Key findings of baseline assessment:
- Health-related quality of life is impaired in both severe/moderate and mild painful DSPN: Both severe/moderate and mild neuropathic pain were associated with poorer physical and mental health-related quality of life compared with painless DSPN.
- Painful DSPN remains undertreated: Only 42% of participants with severe/moderate painful DSPN received any pharmacotherapy for DSPN, and only 28% received analgesic pharmacotherapy.
- Gaps in treatment and patient awareness remain: Among participants with painless DSPN, 7% received analgesic drugs that the authors noted they presumably did not need, while 31% had not been told by their physician that they had diabetic neuropathy.
Standardized assessment and point-of-care screening tools are underused: Only about 15% of physicians used the NDS to assess neuropathic deficits, while clinical screening tools such as the tuning fork, 10 g monofilament, and thermal testing devices were used inconsistently in routine practice.
PROTECT Study
The PROTECT study investigated the prevalence and risk factors of DSPN. A total of 1,850 people with and without known diabetes participated in foot nerve checks at public awareness events held in 47 cities over five years. Tests included pressure, temperature, vibration sensation, and foot pulses. The data were analyzed at the German Diabetes Center (Heinrich Heine University Düsseldorf) and published internationally.2
Key findings:
- About 1 in 2 participants showed signs of neuropathy.
- 70% of those detected with neuropathy had been previously undiagnosed.
- Nearly 40% of participants without known diabetes had prediabetic or diabetic HbA1c levels, indicating undiagnosed diabetes as a major cause of neuropathy.
PROTECT Follow-Up Study
In a follow-up study, participants from the PROTECT study were surveyed again 2.5 years after the initial assessment to evaluate the progression of neuropathy and its treatment. Questionnaires from 122 participants with type 2 diabetes and 85 without diabetes were analyzed at the German Diabetes Center (Heinrich Heine University Düsseldorf) and published internationally.3
Key findings:
- In about 50% of participants, neuropathic symptoms had worsened.
- Despite this, more than one third of participants with neuropathic symptoms received no pharmacological treatment.
PROTECT Study Survey
To better understand diagnostic practices in routine care of physicians (n=574) in Germany, a cross-sectional survey (general practitioners, internists, and diabetologists) was conducted. The survey data were analyzed at the German Diabetes Center (Heinrich Heine University Düsseldorf) and published internationally.4
Key findings:
- 87% reported screening patients with diabetes for DSPN at least once a year.
- Only 28% and 20% used questionnaires or clinical scores to assess symptom severity or neurological deficits.
- More than half did not follow a standardized approach for bedside sensory testing.
- Only 50% based their diagnosis of DSPN on clinical guidelines.
PROTECT Study Survey 2
A survey was conducted to assess the daily practice of podiatrists, with a focus on screening, monitoring, and foot care in patients with DSPN. A total of 125 podiatrists from 12 federal states in Germany completed an online questionnaire. The data were analyzed at the German Diabetes Center (Heinrich Heine University Düsseldorf) and published internationally.5
Key findings:
- DSPN screening or follow-up was performed annually by 36%, only at initial assessment by 28%, only when suspected by 21%, and at every visit by 10%.
- Previously by physicians undiagnosed DSPN and foot ulcers were frequently detected by podiatrists (≈6 cases/month) by 24.0% and 18.4% of podiatrists, respectively.
Conclusion:
Podiatrists in Germany play a crucial role in the detection, monitoring, and management of DSPN and diabetic foot ulcers.
PROTECT Study Survey 3
In an online survey of 114 podiatrists from 12 German federal states, the PROTECT Study assessed interdisciplinary collaboration between podiatrists and physicians in the management of DSPN.
- 95.2% of podiatrists would like better collaboration with referring physicians; 94.7% identified physician education on the importance and reimbursement eligibility of podiatric services as relevant.
- DSPN findings are most often communicated via patients (57.3%); only 6.3% use a structured findings report, while around 17% do not communicate findings.
- 90.1% would like DSPN educational materials for patients; overall, the authors see a clear need to improve collaboration, communication of findings, and appreciation of podiatry.
Conclusion:
Interdisciplinary collaboration between podiatrists and physicians in Germany needs substantial improvement, particularly regarding structured communication, recognition of podiatric services, and patient education on DSPN.
(Link/reference will be provided later)6
International expert consensus recommendations for the screening, diagnosis, and management of DSPN in routine clinical practice
This publication provides evidence‑based algorithms covering early detection, clinical diagnosis, and a comprehensive treatment approach combining lifestyle measures, pathogenetic therapies, and symptomatic pain management to improve patient outcomes and quality of life. Published internationally.7
American Diabetes Association Clinical Compendium on diagnosis and treatment of Painful Diabetic Peripheral Neuropathy
This American Diabetes Association (ADA) Clinical Compendium provides a comprehensive, practice‑oriented overview of the diagnosis and management of diabetic peripheral neuropathy, with particular emphasis on painful DSPN and a strong focus on pathogenetically oriented treatments alongside symptomatic pain control to improve long‑term outcomes and quality of life.8
More effective strategies are needed to ensure the timely diagnosis of both neuropathy and diabetes.
Effective measures are needed to address inadequate treatment, poor adherence, and the limited effectiveness of pharmacological therapies.
(1) PREDIP: Ziegler D, Fietz C, Keuthage W, Lobmann R, Rett K, Reule C, Rudolf S, Scheper N, Schnell O, Serban PM, Sjomin J, Stirban OA, Strom A, Ströhl J, Jaghutriz BA. Health-related quality of life and management routine in painful and painless diabetic polyneuropathy (PREDIP study). Diabetes Res Clin Pract. 2026 Aug;238:113403.
(2) PROTECT: Ziegler D, Landgraf R, Lobmann R, Reiners K, Rett K, Schnell O, Strom A. Painful and painless neuropathies are distinct and largely undiagnosed entities in subjects participating in an educational initiative (PROTECT study). Diabetes Res Clin Pract. 2018 May;139:147-154. doi: 10.1016/j.diabres. 2018.02.043.
(3) PROTECT follow-up study: Ziegler D, Landgraf R, Lobmann R, Reiners K, Rett K, Schnell O, Strom A. Polyneuropathy is inadequately treated despite increasing symptom intensity in individuals with and without diabetes (PROTECT follow-up study). J Diabetes Investig. 2020 Sep;11(5):1272-1277.
(4) PROTECT study survey: Ziegler D, Landgraf R, Lobmann R, Reiners K, Rett K, Schnell O, Strom A. Screening and diagnosis of diabetic polyneuropathy in clinical practice: A survey among German physicians (PROTECT Study Survey). Prim Care Diabetes. 2022 Dec;16(6):804-809. doi: 10.1016/j.pcd.2022.09.009.
(5) PROTECT study survey 2: Ziegler D, Burow S, Landgraf R, Lobmann R, Reiners K, Rett K, Schnell O. Current Practice of Podiatrists in Testing for Diabetic Polyneuropathy and Implementing Foot Care (PROTECT Study Survey 2). Endocr Pract. 2024 Sep;30(9):817-821. doi: 10.1016/j.eprac.2024.06.006.
(6) PROTECT study survey 3: Reference will be provided as soon published
(7) Consensus recommendations: Ziegler D, Tesfaye S, Spallone V, Gurieva I, Al Kaabi J, Mankovsky B, Martinka E, Radulian G, Nguyen KT, Stirban AO, Tankova T, Varkonyi T, Freeman R, Kempler P, Boulton AJ. Screening, diagnosis and management of diabetic sensorimotor polyneuropathy in clinical practice: International expert consensus recommendations. Diabetes Res Clin Pract. 2022 Apr;186:109063. doi: 10.1016/j.diabres.2021.109063.
(8) Expert recommendations (American Diabetes Association (ADA) compendium): Pop-Busui R, Ang L, Boulton AJM, Feldman EL, Marcus RL, Mizokami-Stout K, Singleton JR, Ziegler D. Diagnosis and Treatment of Painful Diabetic Peripheral Neuropathy. Arlington (VA): American Diabetes Association; 2022 Feb. PMID: 35544662.Pop-Busui R, Ang L, Boulton AJM, Feldman EL, et al. Arlington (VA): American Diabetes Association; 2022 Feb. PMID: 35544662.