Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924036
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2021-06-07
Brief Title:
Qbrexza Cloths for Hyperhidrosis of Amputation Sites
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
A Prospective Trial to Assess How Glycopyrronium Cloths at the Amputation Site of Limb Amputees Changes the Severity of Hyperhidrosis and the Fit and Function of the Prosthetic Measured by Patient Reported Outcomes
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Prospective Double Blinded Placebo Controlled Randomized Cross-over trial using Qbrexza Cloths to treat hyperhidrosis of amputation sites There is a 2 week screening period where patients will use an activity monitor to establish baseline activity level then patients will be randomized to receive either Qbrexza cloths or placebo for 4 weeks then a 2 week washout and then a 4-week cross-over treatment period
Detailed Description:
BACKGROUND
Approximately 1 in 190 people in the United States have experienced a limb amputation Of these patients with amputations over sixty percent suffer from hyperhidrosis at the amputation site Amputation site hyperhidrosis interferes with these patients daily activities as well as their ability to engage in vigorous activity beneficial to their overall health In fact amputees identified heat and sweating as what reduces their quality of life more than any other problem even pain Despite the significant impact hyperhidrosis has on amputees quality of life and ability to stay physically active there are no self-administered non-invasive well-tolerated treatments for amputation site hyperhidrosis Botulinum toxin injections are an available treatment option for focal hyperhidrosis However the large surface area covered by the prosthetic and prosthetic sleeve often necessitates very large volumes of botulinum toxin for effective treatment at amputation sites This is costly making it difficult to be able to treat the entire affected area Botulinum toxin also requires office visits and repeat treatments every 4-6 months
Glycopyrronium cloths are a unique treatment possibility because they can easily be used over a large body surface area and can easily be self-administered at home At this time glycopyrronium cloths are only FDA approved for use in the axillae There are two primary differences between the use of these cloths at amputation sites and axillae 1 the amputation site is occluded during daytime hours by the prosthetic and 2 the area treated for amputation-site hyperhidrosis the entire area covered by the prosthetic sleeve is typically a much larger surface area than the axillae These factors could significantly increase systemic absorption of glycopyrronium and cause systemic side effects In order to minimize these effects the medication will be applied at night when the site is not occluded Frequent visits with the investigator will also encourage early reporting of symptoms which could be the result of systemic side effects associated with use on a larger surface area Patient reported outcomes will be used to determine effectiveness
This is a Prospective Double Blinded Placebo Controlled Randomized Cross-over trial
Participants will be randomized using a 11 ratio to one of 2 arms
Arm 1 At Baseline participants will receive active treatment for 4 weeks completing a 1 week wash out period and then concluding with 4 weeks of placebo treatment
Arm 2 At baseline participants will receive placebo for 4 weeks completing a 1 week washout period and then concluding with active treatment for 4 weeks
Approximately 1 in 190 people in the United States have experienced a limb amputation Of these patients with amputations over sixty percent suffer from hyperhidrosis at the amputation site Amputation site hyperhidrosis interferes with these patients daily activities as well as their ability to engage in vigorous activity beneficial to their overall health In fact amputees identified heat and sweating as what reduces their quality of life more than any other problem even pain Despite the significant impact hyperhidrosis has on amputees quality of life and ability to stay physically active there are no self-administered non-invasive well-tolerated treatments for amputation site hyperhidrosis Botulinum toxin injections are an available treatment option for focal hyperhidrosis However the large surface area covered by the prosthetic and prosthetic sleeve often necessitates very large volumes of botulinum toxin for effective treatment at amputation sites This is costly making it difficult to be able to treat the entire affected area Botulinum toxin also requires office visits and repeat treatments every 4-6 months
Glycopyrronium cloths are a unique treatment possibility because they can easily be used over a large body surface area and can easily be self-administered at home At this time glycopyrronium cloths are only FDA approved for use in the axillae There are two primary differences between the use of these cloths at amputation sites and axillae 1 the amputation site is occluded during daytime hours by the prosthetic and 2 the area treated for amputation-site hyperhidrosis the entire area covered by the prosthetic sleeve is typically a much larger surface area than the axillae These factors could significantly increase systemic absorption of glycopyrronium and cause systemic side effects In order to minimize these effects the medication will be applied at night when the site is not occluded Frequent visits with the investigator will also encourage early reporting of symptoms which could be the result of systemic side effects associated with use on a larger surface area Patient reported outcomes will be used to determine effectiveness
This is a Prospective Double Blinded Placebo Controlled Randomized Cross-over trial
Participants will be randomized using a 11 ratio to one of 2 arms
Arm 1 At Baseline participants will receive active treatment for 4 weeks completing a 1 week wash out period and then concluding with 4 weeks of placebo treatment
Arm 2 At baseline participants will receive placebo for 4 weeks completing a 1 week washout period and then concluding with active treatment for 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None