NCT04154020: TODDII

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

Completed NA Last updated 29 October 2021

What this trial tests

NA trial testing Flexor tenotomy in Diabetic Foot Ulcer in 21 participants. Completed in 28 October 2021.

Timeline

30 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	treatment
Enrollment	21
Start date	30 November 2019
Primary completion	3 August 2021
Estimated completion	28 October 2021
Sites	3 locations across Denmark

Drugs / interventions tested

• Flexor tenotomy

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
• 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 Ulcer or Hammer Toe. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. Aim Patients with diabetes, hammer, mallet and claw toes and ulcers associated with the named deformities will be randomized to tenotomy (cutting) of flexor tendons to the afflicted toes, done by needle and standard offloading or offloading alone. The effects of the surgery on time to healing of ulcers associated with the named deformities, recurrence of the ulcers, and rate of complications associated with the surgery. In addition to this all patients gait and balance will be examined before start of the study, and after 3 months, to se if there is an effect of the surgery on patients gait and balance.
2. Method A prospective randomized clinical study, which means a study were patients will be allocated randomly to surgery and standard care or standard care alone.

Patients will attend a total of up to 14 visits over a 12-month period.

3\.

Publications & conference data

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

1. 58^th 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
2. 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