Hyperhidrosis in Patients With Amputations-Botox

NCT03236012 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: IRB_107999OP150030
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

The objective is to establish and evidence base for hyperhidrosis treatment algorithm in amputees.This project will address a problem that has troubled Service members, Veterans, and civilians with amputations for decades, impacting satisfaction with prosthetic use, residual limb skin health, and negatively affecting quality of life. Prior research in this area has been limited and insufficient. We plan to conduct an open label study of Botox, up to 400 units, to treat limb hyperhidrosis in patients with amputations. The actual dose of Botox used will be based on individual results with the Iodine-Starch test to identify areas on the residual limb that are producing excessive sweat. Botulinum Toxin A (BTX-A): Botulinum toxin therapy is well-established for use in excessive sweating of several body areas (axillary, palmar, plantar, and facial) in individuals with hyperhidrosis and inadequate response to topical treatments. Extensive research has been conducted on the efficacy and safety of BTX-A for hyperhidrosis of other areas, and it has been shown to improve both objective and subjective measures of sweating, and lead to improved quality of life measures. This will be accomplished by completing the following: Test the validity of the Minor iodine-starch test in amputees.

1. 1.Hypothesis: The iodine-starch test is a valid diagnostic tool of hyperhidrosis and can be useful for the identification of focal areas of sweating on a residual limb.
2. 2.Treat the residual limb Hyperhidrosis with Botox, up to and limited to 400 units.

Conditions

Hyperhidrosis

Keywords

amputation, amputations, sweating, residual limb,

Outcome Measures

Primary Outcomes (1)

• The effectiveness of botulinum toxin therapy in subjects who fail Aluminum Chloride as assessed by the Hyperhidrosis Disease Severity Scale (HDSS)

  The outcome measure for this study will be measuring the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS is scored on a number scale of 1-4. Score range from 1 (lowest) demonstrating sweating (hyperhidrosis) is least noticeable and does not interfere with daily activities (least impactful) to 4 (highest) sweating is intolerable and interferes significantly with daily activities. This measurement will be completed at Baseline, Week #4 clinic visit, Week #12 clinic visit, Week#16 clinic visit and week#20 follow up phone call visit.

  Baseline to 20 weeks

Secondary Outcomes (1)

• The effectiveness of botulinum toxin therapy in subjects who fail Aluminum Chloride as assessed by the Sweating Intensity Visual Scale (SIVS)

  Baseline to 20 weeks

Study Arms (1)

Botulinum Toxin Therapy

EXPERIMENTAL

Test the effectiveness of Botulinum Toxin therapy in subjects who fail or do not tolerate Aluminum Chloride. We plan to conduct an open label study of Botox, up to 400 units, in amputees who have failed treatment with a topical antiperspirant.

Drug: Botulinum Toxin Type A (Botox)

Interventions

Botulinum Toxin Type A (Botox) DRUG

Maximum dose up to 400 units given one time

Also known as: Manual Muscle Testing (MMT), Labs (CBC, BMP, PFT'S, (FEV1 & FVC)), Iodine Starch Skin Test

Botulinum Toxin Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form (ICF)
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, age 18 or older
• At least 6 months post-amputation surgery
• Have a prosthetic device
• In good general health as evidenced by medical history
• HDSS score of 2 or greater AND failed prior treatment with topical Aluminum Chloride.
• At least 6 months from last injection with any botulinum toxin

You may not qualify if:

• Open sores or wounds on the residual limb
• Known sensitivity or allergy to iodine
• Pregnancy or lactation
• Any prior Hypersensitivity reaction to Botox including anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea
• Infection at the injection site
• Known neuromuscular junction disorder
• Inflammation at the injection site
• A known compromised respiratory status which may include the use of oxygen, recent hospitalization for respiratory illness, including but not limited to recent antibiotic treatment for pneumonia, bronchitis or other respiratory tract infections will not be allowed to participate
• Overactive bladder with a history of recurrent urinary tract infection (UTI) or two or more UTI's

Sponsors & Collaborators

• University of Utah: lead
• US Department of Veterans Affairs: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Botulinum Toxins, Type A; 2-methylcyclopentadienyl manganese tricarbonyl; Blood Cell Count; Bone Morphogenetic Proteins; Vital Capacity

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; TGF-beta Superfamily Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Respiratory Physiological Phenomena

Study Officials

• Colby Hansen, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: For this study, subjects will be recruited from the amputee clinics held at the Salt Lake Veteran Affairs (VA) Medical Center or the University of Utah. Combined, these clinics serve approximately 500 patients and see approximately 75 new patients each year. We plan to recruit a total of 25 subjects to this project from the two study sites. It is expected that we will enroll equal numbers from both the University of Utah and VA Medical Center.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: January 8, 2019
• Primary Completion: January 15, 2022
• Study Completion: February 14, 2022
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

US (2)