Active — Not RecruitingNot Applicable

Geko™ Cross Therapy Registry - Wound

United States, United Kingdom2,500 participantsStarted 2022-04-04

Plain-language summary

The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged ≥ 18 years
✓. Intact healthy skin at the site of geko™ device application.
✓. Willing and able to give written informed consent
✓. Presence of an ulcerative wound to the lower leg
✓. Identified to receive geko™ therapy as part of their standard care for wound management.

Exclusion criteria

✕. Pregnancy or breast feeding.
✕. Use of any other neuro-modulation device.
✕. Current use of TENS in the pelvic region, back or legs
✕. Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
✕. No response to geko™ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting

What they're measuring

Frequency of adverse events

Timeframe: Up to 12 months from study entry

Frequency of serious adverse events

Timeframe: Up to 12 months from study entry

Frequency of device deficiencies

Timeframe: Up to 12 months from study entry

Trial details

NCT IDNCT05007301

SponsorFirstkind Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Wound trials