Session Information
Session Time: None. Available on demand.
Disclosures: Colby R. Hansen, MD: No financial relationships or conflicts of interest
Background and/or Objectives: Residual limb hyperhidrosis is a significant problem for many patients with amputation that can impact their skin health and prosthetic fit and function. Aluminum Chloride 20% (AlCl) is generally considered an appropriate 1st line treatment for hyperhidrosis of other body areas.
Design: Double blind 4 period randomized controlled trial of AlCl vs placebo. Registered under clinicaltrials.gov (NCT03416348)
Setting: Academic Medical Center and VA Hospital
Participants: Adult amputees at least 6 months removed from amputation who utilize a prosthetic device and note at least mild hyperhidrosis as defined by Hyperhidrosis Disease Severity Scale (HDSS) score of 2 or greater.
Interventions: Three times weekly AlCl or placebo for 3 weeks applied to the portion of the residual limb which interfaces with a prosthesis in a 4 period crossover trial. Subjects alternated between active and placebo treatment through 4 periods for a total 12 week trial. Outcome measures (HDSS score) were obtained at the end of each 3 week period.
Main Outcome Measures: Change in HDSS score from baseline, proportion of subjects reporting improved HDSS score by AlCl or placebo condition
Results: 31 subjects were enrolled in study procedures. There were 23 male (74%) and 8 female participants. Average age was 48.6 years (range 21 – 73). Compared to baseline HDSS, 32.7% of the time subjects had improvement in HDSS score with AlCl treatment as compared to 40.7% of the time with placebo. 60% of subjects had no change in HDSS score with AlCl treatment compared to 54.2% with placebo. To account for the repeated crossover design, a logistic regression of cumulative proportion for the ordinal response showed active treatment was not superior to placebo at improving HDSS score (p = 0.1031).
Conclusions: AlCl is not superior to placebo at treating residual limb hyperhidrosis in amputees.
Level of Evidence: Level I
To cite this abstract in AMA style:
Hansen CR, Mountan SE, Godfrey BS, Kuo KT, Balch AH. Aluminum Chloride vs Placebo for Residual Limb Hyperhidrosis: A Double Blind Randomized Controlled Crossover Trial [abstract]. PM R. 2022; 14(S1)(suppl 1). https://pmrjabstracts.org/abstract/aluminum-chloride-vs-placebo-for-residual-limb-hyperhidrosis-a-double-blind-randomized-controlled-crossover-trial/. Accessed May 18, 2025.« Back to AAPM&R Annual Assembly 2022
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/aluminum-chloride-vs-placebo-for-residual-limb-hyperhidrosis-a-double-blind-randomized-controlled-crossover-trial/