Cross Therapy Registry - Edema - US

Edema Leg Clinical Trial

— CTR-Edema-US  

Official title:

Cross Therapy Registry - Edema Post Market Clinical Follow-up of Safety and Patient Outcomes for Subjects Undergoing Peroneal Nerve Stimulation by Geko™.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700735
• Other study ID #: FSK-REG-001-US
• Status: Completed
• Start date: June 22, 2021
• Est. completion date: November 9, 2023

Study information

• Verified date: February 2024
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months.

Description:

The geko™ device has a wide range of clinical applications including the post-operative management of edema.

Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for edema management on patient outcomes during follow-up of up to twelve months.

As the manufacturer of the device, Firstkind Limited has an obligation to collect safety and performance data to comply with current regulations (MDR EU 2017/745 Annex XIV, Part B). Consequently, there is a need for an observational study to provide data to demonstrate patient benefit and regulatory compliance.

The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months. This study forms part of the overall Post-Market Clinical Follow-up strategy for the device and Post Market Surveillance (PMS) to support device and performance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: November 9, 2023
• Est. primary completion date: August 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged = 18 years and able to provide written informed consent.

• Intact healthy skin at the site of gekoTM device application.

• Subjects receiving gekoTM therapy as part of their standard care for edema reduction.

Exclusion Criteria:

• Pregnancy or breast feeding.

• Use of any concurrent neuro-modulation device.

• Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.

• No involuntary movement of the lower leg/foot at the maximum tolerable device setting.

• Bilateral lower limb surgical intervention.

• Unicondylar knee replacement surgical intervention.

Related Conditions & MeSH terms

• Edema
• Edema Leg

Intervention

Device:
• geko Neuromuscular Electro Stimulator (NMES)
Neuromuscular Electro Stimulator (NMES)

Locations

Country	Name	City	State
United States	Luminis Health Research Institute	Annapolis	Maryland
United States	JIS Orthopedics	New Albany	Ohio
United States	Genesee Orthopedics	New Hartford	New York

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United States, 

References & Publications (17)

Barnes R, Madden LA, Chetter IC. Fibrinolytic effects of peroneal nerve stimulation in patients with lower limb vascular disease. Blood Coagul Fibrinolysis. 2016 Apr;27(3):275-80. doi: 10.1097/MBC.0000000000000409. — View Citation

Griffin M, Bond D, Nicolaides A. Measurement of blood flow in the deep veins of the lower limb using the geko neuromuscular electro-stimulation device. Int Angiol. 2016 Aug;35(4):406-10. Epub 2016 Mar 2. — View Citation

Harris C, Duong R, Vanderheyden G, Byrnes B, Cattryse R, Orr A, Keast D. Evaluation of a muscle pump-activating device for non-healing venous leg ulcers. Int Wound J. 2017 Dec;14(6):1189-1198. doi: 10.1111/iwj.12784. Epub 2017 Aug 2. — View Citation

Harris C, Ramage D, Boloorchi A, Vaughan L, Kuilder G, Rakas S. Using a muscle pump activator device to stimulate healing for non-healing lower leg wounds in long-term care residents. Int Wound J. 2019 Feb;16(1):266-274. doi: 10.1111/iwj.13027. Epub 2018 Nov 20. — View Citation

Jawad H, Bain DS, Dawson H, Crawford K, Johnston A, Tucker A. The effectiveness of a novel neuromuscular electrostimulation method versus intermittent pneumatic compression in enhancing lower limb blood flow. J Vasc Surg Venous Lymphat Disord. 2014 Apr;2(2):160-5. doi: 10.1016/j.jvsv.2013.10.052. Epub 2014 Jan 28. — View Citation

Jones NJ, Ivins N, Ebdon V, Hagelstein S, Harding KG. Neuromuscular electrostimulation on lower limb wounds. Br J Nurs. 2018 Nov 8;27(20):S16-S21. doi: 10.12968/bjon.2018.27.Sup20.S16. — View Citation

Loyd BJ, Kittelson AJ, Forster J, Stackhouse S, Stevens-Lapsley J. Development of a reference chart to monitor postoperative swelling following total knee arthroplasty. Disabil Rehabil. 2020 Jun;42(12):1767-1774. doi: 10.1080/09638288.2018.1534005. Epub 2019 Jan 22. — View Citation

Loyd BJ, Stackhouse S, Dayton M, Hogan C, Bade M, Stevens-Lapsley J. The relationship between lower extremity swelling, quadriceps strength, and functional performance following total knee arthroplasty. Knee. 2019 Mar;26(2):382-391. doi: 10.1016/j.knee.2019.01.012. Epub 2019 Feb 14. — View Citation

Mahmood, Ihsan FRCS (T&O); Chandler, Henry MRCS; Kottam, Lucksy PhD; Eardley, William FRCS (T&O); Rangan, Amar FRCS (T&O); Baker, Paul FRCS (T&O) Neuromuscular Electrostimulation Device Reduces Preoperative Edema and Accelerates Readiness for Theater in Patients Requiring Open Reduction Internal Fixation for Acute Ankle Fracture, Techniques in Foot & Ankle Surgery: December 2020 - Volume 19 - Issue 4 - p 215-219 doi: 10.1097/BTF.0000000000000257

Pichonnaz C, Bassin JP, Lecureux E, Currat D, Jolles BM. Bioimpedance spectroscopy for swelling evaluation following total knee arthroplasty: a validation study. BMC Musculoskelet Disord. 2015 Apr 25;16:100. doi: 10.1186/s12891-015-0559-5. — View Citation

Tucker A, Maass A, Bain D, Chen LH, Azzam M, Dawson H, Johnston A. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol. 2010 Spring;19(1):e31-7. doi: 10.1055/s-0031-1278361. — View Citation

Virchow, R. (1856).

Wainwright TW, Burgess LC, Middleton RG. A feasibility randomised controlled trial to evaluate the effectiveness of a novel neuromuscular electro-stimulation device in preventing the formation of oedema following total hip replacement surgery. Heliyon. 2018 Jul 18;4(7):e00697. doi: 10.1016/j.heliyon.2018.e00697. eCollection 2018 Jul. — View Citation

Warwick DJ, Shaikh A, Gadola S, Stokes M, Worsley P, Bain D, Tucker AT, Gadola SD. Neuromuscular electrostimulation viathe common peroneal nerve promotes lower limb blood flow in a below-kneecast: A potential for thromboprophylaxis. Bone Joint Res. 2013 Sep 2;2(9):179-85. doi: 10.1302/2046-3758.29.2000176. Print 2013. — View Citation

Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10. — View Citation

Yilmaz S, Calbiyik M, Yilmaz BK, Aksoy E. Potential role of electrostimulation in augmentation of venous blood flow after total knee replacement: A pilot study. Phlebology. 2016 May;31(4):251-6. doi: 10.1177/0268355515580473. Epub 2015 Apr 6. — View Citation

Zhang Q, Styf J, Ekstrom L, Holm AK. Effects of electrical nerve stimulation on force generation, oxygenation and blood volume in muscles of the immobilized human leg. Scand J Clin Lab Invest. 2014 Aug;74(5):369-77. doi: 10.3109/00365513.2014.898323. Epub 2014 Apr 3. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety: determine frequency of adverse events (AEs) and serious AEs (SAEs) whether device related or not and compare rate to historic and published data i.e. gekoTM vs standard of care (SC).	One year
Primary	Performance	Performance: determine frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e. gekoTM vs SC.	One year
Secondary	Summary of routinely collected performance data	Summarize routinely tested and collected performance data, such as patient reported outcome measures and compare to historic and published data i.e. gekoTM vs SC.	One Year
Secondary	Summary of Health Economic Impact	Summarize health economic impact of gekoTM device on patient outcomes in comparison to SC.	One year