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

NCT04154046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-11-01

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Foot
  • Hammer Toe
  • Mallet Toe
  • Claw Toe

Interventions

PROCEDURE

Tenotomy(cutting) of flexor tendons is performed with needle

Patient is placed in seated posture with feet elevated. The toe(s) with hammer, mallet or claw toe deformity is anesthetized by a digital toe block with 1-5 ml of 1% lidocaine administered for each toe. The toe digital block is administered through a plantar approach, at the web level of the deformed toe(s), with a 0,6 mm diameter and 30mm long needle. After anesthetizing the toe(s) the plantar aspect of the toe at web level is disinfected with an alcohol based disinfectant twice. Both the long and short flexors are then severed with a 1.2mm diameter and 40mm long needle through a plantar approach, immediately proximal to the web level of the toe. After the procedure a dry gauze bandage is applied and the patients treated foot/feet is/are elevated for 20 minutes to achieve haemostasis, and the bandage is checked for bleeding before discharge.

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • Hillerod Hospital, Denmark

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-08-03
Completion
2021-10-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04154046 on ClinicalTrials.gov