Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001015235
Ethics application status
Approved
Date submitted
6/06/2018
Date registered
18/06/2018
Date last updated
18/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The safety and effectiveness of tendon release in healing toe ulcers
Scientific title
The safety and effectiveness of the percutaneous flexor tenotomy in healing neuropathic apical toe ulcers in the outpatient setting
Secondary ID [1] 295021 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Ulcer 308037 0
Condition category
Condition code
Metabolic and Endocrine 307086 307086 0 0
Diabetes
Musculoskeletal 307087 307087 0 0
Other muscular and skeletal disorders
Public Health 307088 307088 0 0
Other public health
Skin 307089 307089 0 0
Other skin conditions
Surgery 307090 307090 0 0
Surgical techniques
Surgery 307091 307091 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aims of this study were to assess the effectiveness and utility of percutaneous flexor tenotomy in healing neuropathic apical toe ulcers when performed in an outpatient clinical setting by a podiatric surgeon; to prevent progression of apical toe pre-ulcerative lesions to frank ulceration; and to assess the satisfaction of participants who undergo percutaneous flexor tenotomy in the outpatient setting.

Data collection included participant demographic, health status and clinical characteristics. Data collection was performed at either a pre-procedure appointment, or on the day of the procedure, and then at a 3- and 6-month post-procedure follow up appointment. Demographic data included participant age, gender, body mass index, waist circumference. Health status data included diabetes type, presence of loss of protective sensation, cardiovascular, pulmonary and renal comorbidities, rheumatic disease, depression and smoking status. Clinical measures included the presence of concomitant foot deformity including hallux valgus, hallux rigidus, ankle equinus, charcot neuroarthropathy and history of ipsilateral and contralateral pedal amputation. Toe ulcer clinical information was collected, including ulcer location, duration of ulceration, history of previous ulcer or toe infection, presence of active infection, ulcer measurement using disposable paper ruler (mm) and grading of the ulcer according to the University of Texas Wound Classification grade and stage. In the participants with pre-ulcerative lesions, history of ulceration and infection were recorded. The presence of toe deformity affecting the respective toe was also assessed, including mallet, hammer or claw toe deformity and whether the deformity was flexible, semi-flexible or rigid. Loss of protective sensation was assessed with 10g Semmes-Weinstein monofilament. Vascular assessment included pulse palpation and ankle-brachial indices. Toe pressure was recorded and toe-brachial indices determined. In the instances where participants had previously undergone 1st toe or ray amputation, toe pressure was determined on a lesser toe not affected by active ulceration.

Procedure details were recorded, including the date of the procedure, whether isolated long flexor tenotomy or short and long flexor tenotomy were performed. Time to ulcer healing was recorded (days) as well as any procedure complications. These included infection of the procedure site, participant reported balance problems, re-ulceration of the toe and the development of a transfer lesion or ulceration to an adjacent digit post tenotomy. Following ulcer and/ or procedure incision healing, each participant completed a satisfaction questionnaire.

Tenotomy Procedure
All local anaesthesia and tenotomy procedures were undertaken by the podiatric surgeon (primary author). Each participant was reclined in a supine position in a treatment chair. In circumstances where participants requested anaesthesia (despite loss of protective sensation as determined by the Seimmes-Weinstein monofilament), local anaesthesia was undertaken in the form of a digital (toe) field blockade. This was performed under aseptic technique with 1% lignocaine plain. The podiatric surgeon then gloved and gowned according to the Australian College of Perioperative Nurses standards. The forefoot was prepped with 10% povidone iodine solution and draped with a sterile towel and sterile aperture drape. The flexor digitorum longus and/ or brevis was placed under tension (‘bowstringing’) by requesting the participant to “claw their toes”. When a participant was unable to effectively claw their toes, the ankle joint was positioned in dorsiflexion, while at the same time positioning the affected toe in hyperextension. A controlled stab incision was made using a no.18g needle or fine scalpel blade (no.61 chisel blade) at the proximal flexor crease or distal flexor crease, depending on whether the short flexor or long flexor tendon was to be released. With the tendon under tension, the needle or fine scalpel blade was then moved carefully in a side to side manner to effect tenotomy. Successful long flexor tenotomy was observed with loss of power to the distal aspect of the toe. Successful long and short flexor tenotomy was observed with loss of flexor power to the toe from the proximal interphalangeal joint. All stab incisions were dressed with Betadine, sterile foam and dressing tape. In cases where the tenotomy was performed in the presence of an active ulceration, the respective ulcer was dressed with cadexomer iodine and sterile foam; and secured with dressing tape. A postoperative shoe was provided for use in the healing period. Each participant kept the respective dressing intact and dry for 7-days.

Each participant was examined at 1-week post procedure, and then at 1-week follow-up intervals, until incision healing, in cases of prophylactic tenotomy; or until ulcer healing. Once the toe ulcer or incision was healed, the patient was scheduled for a 3-month and 6-month follow up appointment.
Intervention code [1] 301350 0
Prevention
Intervention code [2] 301351 0
Treatment: Surgery
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306181 0
Ulcer Healing - as determined by clinical examination (observation of intact/ granulated skin) by primary researcher. Clinical examination of ulcer healing was performed on weekly follow up appointments until ulcer healing was complete.
Timepoint [1] 306181 0
Days (time to ulcer healing) - The length of time of ulcer healing was a primary time point. Participants were followed up weekly until ulcer healing (which was reported in days). Following ulcer healing, the participants were then scheduled for a follow up appointment at 3-months post procedure and for a final follow up appointment at 6-months post procedure. The maximum follow up was 6-months.
Primary outcome [2] 306182 0
Frequency of Apical Toe Ulcer(s). Participants with pre-ulcerative lesions (bruised callus on the tip of their toes) also underwent flexor tenotomy procedure to prevent the pre-ulcerative lesion progressing to an ulcer. The outcome was assessed by clinical examination (observation of intact skin on apex of toe) by primary researcher at 1-week follow up appointment. The participant was then scheduled for a follow up appointment at 3-months and final follow up appointment at 6-months post procedure for clinical observation of the toe(s) to ensure toe remained intact post procedure.
Timepoint [2] 306182 0
6-months post procedure
Primary outcome [3] 306183 0
Procedure Safety (Complication - Infection) - The diagnosis of infection was made with clinical observation for signs of infection (heat, swelling, redness, odour, wound discharge). This was made during clinical examination of the procedure site and ulcer(s) at all follow up appointments until procedure site and/ or ulcer healing.
Timepoint [3] 306183 0
Post Procedure (Immediate post procedure follow up appointments until ulcer or procedure site healing - 7-days to 21 days)
Secondary outcome [1] 347771 0
Complication - Transfer Lesion - The diagnosis of transfer lesion was made with clinical observation. Signs of a transfer lesion is either bruised callus or frank ulceration of an adjacent toe following a tenotomy procedure. This is made with clinical observation for bruised callus or ulcer at the apex of a toe.
Timepoint [1] 347771 0
3-6 month post procedure. The outcome was assessed by clinical examination (observation of intact skin on apex of toe) by primary researcher at all follow up appointments, i.e. until procedure site or ulcer healing and then again at 3-months and 6 months post procedure.
Secondary outcome [2] 347772 0
Patient Satisfaction. This was assessed with a 5-point likert scale questionnaire where participants rated questions as: Strongly Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat Agree and Strongly Agree. The questions included: The procedure was well explained; Risks and benefits were well explained; The Podiatrist was well trained; I am satisfied with the outcome of this procedure; I am satisfied with the follow up care; I experienced problems with the procedure; Any problems I experienced were dealt with quickly and; I would recommend this procedure to others.
Timepoint [2] 347772 0
6-month post procedure
Secondary outcome [3] 348164 0
Falls and Balance Problems. The primary researcher documented whether any participant experienced any problems or concerns with their balance, or if they had a fall during the follow up period. This was based on subjective self report by each participant. No objective tests were utilized to assess balance.
Timepoint [3] 348164 0
3-6 month post procedure. At the 3- and 6- month follow up appointment, the primary researcher documented whether any participant had experienced any problems or concerns with their balance following the procedure(s); or whether any participant had a fall during this period.

Eligibility
Key inclusion criteria
People with diabetes mellitus and loss of protective sensation with an apical toe ulcer or pre ulcerative lesion (bruised callus)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Peripheral Arterial Disease with Toes Pressure <30mmHg
Untreated Cellulitis (Infection)
Intact Sensation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This research project is a prospective case series design
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis will be carried out using descriptive techniques for time to ulcer healing, re-ulceration rate, frequency of complications and patient satisfaction. There is no statistical tests undertaken as part of the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/12/2015
Date of last participant enrolment
Anticipated
Actual
10/11/2017
Date of last data collection
Anticipated
Actual
11/05/2018
Sample size
Target
30
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11084 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 22896 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 299600 0
Hospital
Name [1] 299600 0
Austin Health
Country [1] 299600 0
Australia
Primary sponsor type
Individual
Name
Mr Simon Smith
Address
Austin Health
Podiatry and Foot Ulcer/Charcot's Specialist Clinic
Heidelberg Repatriation Hospital
Waterdale Road
West Heidelberg, Victoria, Australia 3081
Country
Australia
Secondary sponsor category [1] 298919 0
Individual
Name [1] 298919 0
Ms Julie Miller
Address [1] 298919 0
Austin Health
Podiatry and Foot Ulcer/Charcot's Specialist Clinic
Heidelberg Repatriation Hospital
Waterdale Road
West Heidelberg, Victoria, Australia 3081
Country [1] 298919 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300500 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 300500 0
Austin Hospital
145 Studley Road
Heidelberg, Victoria, Australia 3084
Ethics committee country [1] 300500 0
Australia
Date submitted for ethics approval [1] 300500 0
01/09/2015
Approval date [1] 300500 0
24/11/2015
Ethics approval number [1] 300500 0
HREC/15/Austin/413

Summary
Brief summary
The purpose of this study is to assess the effectiveness of the percutaneous flexor tenotomy when performed in the outpatient setting in people with diabetes, digital deformity and loss of protective sensation with a toe ulcer or pre-ulcerative lesion. Percutaneous flexor tenotomy is a minimally invasive procedure that involves cutting one or both tendons underneath the toe using a fine scalpel blade or needle. The procedure serves to remove the deforming force that causes deformity of a toe that generates an ulcer. Percutaneous flexor tenotomy is an alternative to conventional open surgical procedures performed in an operating theatre. Participants enrolled in the study are reviewed weekly until the percutaneous incision is healed, or until ulcer healing. Participants are then followed up at 3- and 6-months post procedure. The time to ulcer healing, re-ulceration rate, frequency of complications, such as infection or transfer lesion (a new onset ulcer or pre ulcerative lesion on an adjacent toe) and patient satisfaction are recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83866 0
Mr Simon Elliot Smith
Address 83866 0
Austin Health
Podiatry and Foot Ulcer/Charcot's Specialist Clinic
Heidelberg Repatriation Hospital
Waterdale Road
West Heidelberg, Victoria, Australia 3081
Country 83866 0
Australia
Phone 83866 0
+61 3 9496 2017 or +61 407 824 775
Fax 83866 0
Email 83866 0
[email protected]
Contact person for public queries
Name 83867 0
Mr Simon Elliot Smith
Address 83867 0
Austin Health
Podiatry and Foot Ulcer/Charcot's Specialist Clinic
Heidelberg Repatriation Hospital
Waterdale Road
West Heidelberg, Victoria, Australia 3081
Country 83867 0
Australia
Phone 83867 0
+61 3 9496 2017 or +61 407 824 775
Fax 83867 0
Email 83867 0
[email protected]
Contact person for scientific queries
Name 83868 0
Mr Simon Elliot Smith
Address 83868 0
Austin Health
Podiatry and Foot Ulcer/Charcot's Specialist Clinic
Heidelberg Repatriation Hospital
Waterdale Road
West Heidelberg, Victoria, Australia 3081
Country 83868 0
Australia
Phone 83868 0
+61 3 9496 2017 or +61 407 824 775
Fax 83868 0
Email 83868 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.