A Phase 2/3 interventional study of Skin biopsy and Lidocaine 5% patches in Diabetic Peripheral Neuropathy, sponsored by Albany Medical College. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Albany Medical College · Phase 2/3, Interventional, and Treatment
The purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Albany Medical College is the lead sponsor of 80 studies on the registry; 14 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.
Procedure: Skin biopsy · Drug: Lidocaine 5% patches
18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.
Procedure: Skin biopsy · Drug: Lidocaine 5% patches
18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study.
Procedure: Skin biopsy · Drug: Lidocaine 5% patches
Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.
Subject will apply patches to affected area QD for 12 hours then remove.
Pain Scores From Composite Visual Analog Scale
Scores range from 0 to 10 with higher scores indicating higher levels of pain.
Time frame: baseline, 4 weeks
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP
Pixel intensity (0-256) of immunofluorescence for each individual biomarker.
Time frame: Baseline, 4 weeks
| Milestone | Healthy Control Patients | Type I or Type II Diabetes With Painful Diabetic Neuropathy | Patients With Non-painful Diabetic Peripheral Neuropathy |
|---|---|---|---|
| Started | 11 | 27 | 13 |
| Completed | 11 | 21 | 12 |
| Not completed | 0 | 6 | 1 |
| Withdrew: Withdrawal by subject | 0 | 4 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Screen failure | 0 | 1 | 0 |
Scores range from 0 to 10 with higher scores indicating higher levels of pain.
| units on a scale | Healthy Control Patients | Type I or Type II Diabetes With Painful Diabetic Neuropathy | Patients With Non-painful Diabetic Peripheral Neuropathy |
|---|---|---|---|
| Baseline | — | 6.5 (4.5 to 9) | 1.2 (0 to 3.1) |
| 4 weeks | — | 4.5 (0 to 8.9) | 0.5 (0 to 1.5) |
Pixel intensity (0-256) of immunofluorescence for each individual biomarker.
| Pixel intensity (0-256) | Healthy Control Patients | Type I or Type II Diabetes With Painful Diabetic Neuropathy | Patients With Non-painful Diabetic Peripheral Neuropathy |
|---|---|---|---|
| Nav1.6-baseline | 81.2 (63.54 to 127.38) | 101.4 (64.69 to 135.5) | 87.9 (49.3 to 126.44) |
| Nav1.6-4 weeks | 91 (49.19 to 132.37) | 90.7 (60.85 to 134.63) | 90.8 (60.38 to 148.07) |
| Nav1.7-baseline | 47.5 (30.84 to 73.33) | 59.6 (39.41 to 87.53) | 54.3 (40.66 to 66.9) |
| Nav1.7-4 weeks | 52.4 (39.82 to 85.83) | 51.5 (30.3 to 81.35) | 54.7 (34.43 to 77.57) |
| CGRP-baseline | 27.7 (22.37 to 32.83) | 38.5 (27.49 to 68.14) | 29.5 (19.51 to 39.83) |
| CGRP-4 weeks | 31.5 (21.86 to 49.53) | 32.8 (19.03 to 56.1) | 26.2 (20.52 to 36.58) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Control Patients | — | 0/11 (0%) | 0/11 (0%) |
| Type I or Type II Diabetes With Painful Diabetic Neuropathy | — | 0/21 (0%) | 0/21 (0%) |
| Patients With Non-painful Diabetic Peripheral Neuropathy | — | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Healthy Control Patients | Type I or Type II Diabetes With Painful Diabetic Neuropathy | Patients With Non-painful Diabetic Peripheral Neuropathy | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 19 | 10 | 40 |
| >=65 years | 0 | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Healthy Control Patients | Type I or Type II Diabetes With Painful Diabetic Neuropathy | Patients With Non-painful Diabetic Peripheral Neuropathy | Total |
|---|---|---|---|---|
| Female | 6 | 9 | 4 | 19 |
| Male | 5 | 12 | 8 | 25 |
Plan to share: No
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Albany Medical College