None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
People with diabetes mellitus and loss of protective sensation with an apical toe ulcer or pre ulcerative lesion (bruised callus)
Exclusion criteria
Peripheral Arterial Disease with Toes Pressure <30mmHg Untreated Cellulitis (Infection) Intact Sensation