Who is sponsoring NCT04154046?

NCT04154046 is sponsored by Steno Diabetes Center Copenhagen.

What drugs are being tested in NCT04154046?

Interventions in NCT04154046: Tenotomy(cutting) of flexor tendons is performed with needle.

What condition does NCT04154046 study?

NCT04154046 studies Diabetic Foot, Hammer Toe, Mallet Toe, Claw Toe.

Is NCT04154046 still recruiting?

NCT04154046 is currently completed. Last updated 1 November 2021.

Last reviewed 2021-11-01 · How we verify

NCT04154046: TODDIII

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Treatment of Impending Ulcers Associated With Hammer, Mallet and Claw Toe Deformities in the Diabetic Patient Setting

Completed NA Last updated 1 November 2021

What this trial tests

NA trial testing Tenotomy(cutting) of flexor tendons is performed with needle in Diabetic Foot in 80 participants. Completed in 28 October 2021.

Timeline

1 November 2019

Primary endpoint
3 August 2021

28 October 2021

Quick facts

Lead sponsor	Steno Diabetes Center Copenhagen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	80
Start date	1 November 2019
Primary completion	3 August 2021
Estimated completion	28 October 2021
Sites	3 locations across Denmark

Drugs / interventions tested

Tenotomy(cutting) of flexor tendons is performed with needle

Conditions studied

Diabetic Foot — all drugs for Diabetic Foot →
Hammer Toe — all drugs for Hammer Toe →
Mallet Toe — all drugs for Mallet Toe →
Claw Toe — all drugs for Claw Toe →

Sponsor

Steno Diabetes Center Copenhagen — full company profile →

Who can join

18 and older, any sex, with Diabetic Foot or Hammer Toe. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with diabetes, hammer, mallet and claw toes and impending ulcers associated with hammer mallet and claw toes will be randomized to tenotomy (cutting) of flexor tendons to the afflicted toes, done by needle and standard offloading or offloading alone. Impending ulcers are defined as callus or nail changes that are known pre-stages to ulcers. The effects of the surgery on incidence of ulcers associated with the named deformities, and rate of complications associated with the surgery.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Transcriptomics-driven drug repositioning for the treatment of diabetic foot ulcer.
Adikusuma W, Zakaria ZA, Irham LM, Nopitasari BL, et al · · 2023 · cited 6× · PMID 37340026 · DOI 10.1038/s41598-023-37120-1
58<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Stockholm, Sweden, 19 - 23 September 2022.
· 2022 · cited 6× · PMID 35920845 · DOI 10.1007/s00125-022-05755-w
Effect of flexor tendon tenotomy of the diabetic hammertoe on plantar pressure: a randomized controlled trial.
Askø Andersen J, Rasmussen A, Engberg S, Bencke J, et al · · 2024 · cited 1× · PMID 39631844 · DOI 10.1136/bmjdrc-2024-004398

Verify or expand the search:

Other recruiting trials for Diabetic Foot

Currently open trials in the same condition.

NCT06487780 — Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers · NA · recruiting
NCT06674980 — Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DF · NA · recruiting
NCT06760416 — Online Diabetic Foot Support Program- Care Kit · NA · active not recruiting
NCT06552910 — Analyzing Anesthetic Techniques in Diabetic Foot Amputation · recruiting
NCT06526936 — The Effect of Foot Care Training Given to Diabetic Hemodialysis Patients on Foot Care Behavior · NA · recruiting

Other Steno Diabetes Center Copenhagen trials

Trials by the same sponsor.

NCT07485075 — Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical · NA · recruiting
NCT07427251 — The Postprandial Hypo-Avoid Study · Phase 4 · not yet recruiting
NCT06954090 — Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study · Phase 4 · enrolling by invitation
NCT06832059 — Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in T · NA · recruiting
NCT07377266 — The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of t · NA · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04154046 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Steno Diabetes Center Copenhagen
Last refreshed: 1 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04154046.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing