Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2020-08-26
2021-10-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Offloading Device for Post Surgical Foot Procedures
NCT03873207
A Test of Efficacy and Foot Position Alteration in Patients Wearing Good Feet Arch Supports for the Treatment of Pain
NCT07103070
Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear
NCT05434078
Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports
NCT00222911
Diagnostic Modeling for Pedal Fat Pad Atrophy
NCT02679651
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Screening includes the following procedures:
1. Performance of a limited physical exam, inclusive of participant's foot exam with a gait and shoe gear evaluation.
2. Medical and surgical history collection
3. Vital signs, medication profile, allergies, height, weight, and BMI calculation.
4. Collection of demographic information
5. 2D Photographs of both feet will be performed
Subjects will be asked to complete:
1. Questionnaires
* Foot and Ankle Ability Measure questionnaire
* Mayo Clinical Scoring System questionnaire
* American Orthopaedic Foot and Ankle Society questionnaire
* Manchester Foot and Ankle Disability Index
* Pittsburgh Foot Survey
2. Diary cards to document for the feet: pain, bruising, redness of the skin, itching, swelling, bleeding, and any concerns/issues not listed, as well as the location, date and day for each noted symptom.
3. Offload Device Distribution. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet. One pair of devices will be given for use in shoe gear, and one pair will be given for use in a slide in the shower.
Follow up visit procedures:
Week 2
1. Collection of vital signs, medication profile, weight, and BMI calculation
2. Limited physical exam with a foot exam
3. Adverse Event Reporting
4. Collection and distribution of feet diary cards
5. 2D Photographs of both feet
6. Foot Assessment Questionnaires
7. Device survey - questions about the fit and feel of the device
Week 4
The same procedures listed for week 2, with the addition of PopSole™ Device removal and final foot diary card collection.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PopSole™ offloading device
This is an external insole device that fits into a shoe and is reusable for a given subject, not for one-time use. It is comparable to other off-the-shelf insoles readily available and presents minimal risk to the participant during the four weeks of study participation.
PopSole™ Offloading Device
Specifically, the PopSole™ Offloading Device allows the provider to pop bubbles in the device (like popping paper or plastic bubble sheeting), thereby offloading the surgical area or area of pain. This customizable approach to offloading may increase compliance as it can easily fit in a normal walking shoe and is personalized for each patient. It can also be attached to a slide for use in the shower. Currently no post-operative devices for offloading the foot can be used in the shower.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PopSole™ Offloading Device
Specifically, the PopSole™ Offloading Device allows the provider to pop bubbles in the device (like popping paper or plastic bubble sheeting), thereby offloading the surgical area or area of pain. This customizable approach to offloading may increase compliance as it can easily fit in a normal walking shoe and is personalized for each patient. It can also be attached to a slide for use in the shower. Currently no post-operative devices for offloading the foot can be used in the shower.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects with foot pain due to forefoot or heel fat pad atrophy or chronic plantar fasciitis as defined by heel pain for greater than 6 months and failed non-surgical therapy
3. Willing and able to comply with follow up examinations
Exclusion Criteria
2. Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet
3. Surgical foot intervention in the last 6 months
4. Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study
5. Neuropathy
6. Any issue that per the physician's determination would render the patient not appropriate to continue participation in the study (compliance, change in physical status, etc.)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jeffrey A. Gusenoff, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jeffrey A. Gusenoff, MD
Professor of Plastic Surgery, & Director, Foot Fat Grafting Institute
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey Gusenoff, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Plastic Surgery, Director of the Foot Fat Grafting Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UPMC Aesthetic Plastic Surgery Center
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gusenoff JA, Mitchell RT, Jeong K, Wukich DK, Gusenoff BR. Autologous Fat Grafting for Pedal Fat Pad Atrophy: A Prospective Randomized Clinical Trial. Plast Reconstr Surg. 2016 Nov;138(5):1099-1108. doi: 10.1097/PRS.0000000000002667.
Minteer DM, Gusenoff BR, Gusenoff JA. Fat Grafting for Pedal Fat Pad Atrophy in a 2-Year, Prospective, Randomized, Crossover, Single-Center Clinical Trial. Plast Reconstr Surg. 2018 Dec;142(6):862e-871e. doi: 10.1097/PRS.0000000000005006.
Swinnen E, Kerckhofs E. Compliance of patients wearing an orthotic device or orthopedic shoes: A systematic review. J Bodyw Mov Ther. 2015 Oct;19(4):759-70. doi: 10.1016/j.jbmt.2015.06.008. Epub 2015 Jul 2.
Jarl G. Methodological considerations of investigating adherence to using offloading devices among people with diabetes. Patient Prefer Adherence. 2018 Sep 12;12:1767-1775. doi: 10.2147/PPA.S175738. eCollection 2018.
Waaijman R, Keukenkamp R, de Haart M, Polomski WP, Nollet F, Bus SA. Adherence to wearing prescription custom-made footwear in patients with diabetes at high risk for plantar foot ulceration. Diabetes Care. 2013 Jun;36(6):1613-8. doi: 10.2337/dc12-1330. Epub 2013 Jan 15.
Polat G, Karademir G, Akalan E, Asik M, Erdil M. Patient compliance with touchdown weight bearing after microfracture treatment of talar osteochondral lesions. J Orthop Surg Res. 2017 Mar 20;12(1):46. doi: 10.1186/s13018-017-0548-5.
Arts ML, de Haart M, Bus SA, Bakker JP, Hacking HG, Nollet F. Perceived usability and use of custom-made footwear in diabetic patients at high risk for foot ulceration. J Rehabil Med. 2014 Apr;46(4):357-62. doi: 10.2340/16501977-1272.
Bus SA, van Deursen RW, Kanade RV, Wissink M, Manning EA, van Baal JG, Harding KG. Plantar pressure relief in the diabetic foot using forefoot offloading shoes. Gait Posture. 2009 Jun;29(4):618-22. doi: 10.1016/j.gaitpost.2009.01.003. Epub 2009 Feb 13.
Wunnemann M, Klein D, Rosenbaum D. Effects of the Twin Shoe (Darco) to compensate height differences in normal gait. Gait Posture. 2011 Jan;33(1):61-5. doi: 10.1016/j.gaitpost.2010.09.025. Epub 2010 Oct 20.
Myers KA, Long JT, Klein JP, Wertsch JJ, Janisse D, Harris GF. Biomechanical implications of the negative heel rocker sole shoe: gait kinematics and kinetics. Gait Posture. 2006 Nov;24(3):323-30. doi: 10.1016/j.gaitpost.2005.10.006. Epub 2005 Nov 21.
Braun BJ, Veith NT, Rollmann M, Orth M, Fritz T, Herath SC, Holstein JH, Pohlemann T. Weight-bearing recommendations after operative fracture treatment-fact or fiction? Gait results with and feasibility of a dynamic, continuous pedobarography insole. Int Orthop. 2017 Aug;41(8):1507-1512. doi: 10.1007/s00264-017-3481-7. Epub 2017 Apr 19.
Bus SA, Maas JC, Otterman NM. Lower-extremity dynamics of walking in neuropathic diabetic patients who wear a forefoot-offloading shoe. Clin Biomech (Bristol). 2017 Dec;50:21-26. doi: 10.1016/j.clinbiomech.2017.10.003. Epub 2017 Oct 2.
Robinson C, Major MJ, Kuffel C, Hines K, Cole P. Orthotic management of the neuropathic foot: an interdisciplinary care perspective. Prosthet Orthot Int. 2015 Feb;39(1):73-81. doi: 10.1177/0309364614545422.
Jarl G, Tranberg R. An innovative sealed shoe to off-load and heal diabetic forefoot ulcers - a feasibility study. Diabet Foot Ankle. 2017 Jul 25;8(1):1348178. doi: 10.1080/2000625X.2017.1348178. eCollection 2017.
de Oliveira AL, Moore Z. Treatment of the diabetic foot by offloading: a systematic review. J Wound Care. 2015 Dec;24(12):560, 562-70. doi: 10.12968/jowc.2015.24.12.560.
Bus SA. The Role of Pressure Offloading on Diabetic Foot Ulcer Healing and Prevention of Recurrence. Plast Reconstr Surg. 2016 Sep;138(3 Suppl):179S-187S. doi: 10.1097/PRS.0000000000002686.
Janisse DJ, Janisse E. Shoe modification and the use of orthoses in the treatment of foot and ankle pathology. J Am Acad Orthop Surg. 2008 Mar;16(3):152-8. doi: 10.5435/00124635-200803000-00006.
Farber SE, Minteer D, Gusenoff BR, Gusenoff JA. The Influence of Fat Grafting on Skin Quality in Cosmetic Foot Grafting: A Randomized, Cross-Over Clinical Trial. Aesthet Surg J. 2019 Mar 14;39(4):405-412. doi: 10.1093/asj/sjy168.
Lubarsky R, Gusenoff B, Gusenoff JA. Prospective Cohort Validation Study of a Novel Foot Offloading Device. Plast Reconstr Surg Glob Open. 2021 Nov 24;9(11):e3950. doi: 10.1097/GOX.0000000000003950. eCollection 2021 Nov.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY20010059
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.