To demonstrate that percutaneous flexor tenotomy is an effective way to treat poorly healing ulcers in diabetic patients with hammertoes. We want to measure this effect by determining the healing time, percentage healed wounds and decrease in size…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure:
- Cure rate of the existing wound on the treated toe.
This is defined as the number of healed wounds on the treated toe, if
complete epithelialization occurred, after a year and is measured in the
absolute number that is healed.
The cure is determined by the classification pedis.
The pedis scale consists of 5 items with the following corresponding
classification:
* Perfusion: 1) absence of PAD, 2) symptoms of PAD, however, no critical
ischemia, 3) existence of critical ischaemia.
* Scope: The size of the ulcer measured in mm x mm after wonddebridement has
taken place.
* Depth: 1) surface, 2) the ulcer penetrates to the subcutaneous structures
such as fascia, muscle or tendon, 3) all underlying layers are involved
including bone and / or
joint.
* Infection: 1) absence of infection, 2) the case of infection of the skin, and
the subcutaneous tissue, 3) erythema greater than 2 cm or deeper than the
skin or subcutis but without systemic inflammatory symptoms, 4) clear
systemic symptoms of infection.
* Sensation: 1) no loss of protective sensation, 2) loss of
protective sensation
- Healing Trend existing wound:
This is defined as the degree of healing, reduction of scale / size wound.
Is determined by the classification pedis.
- Healing Time existing wound to the treated toe.
This is defined by the Nurse practitioner as the time from the interventiondate
until the day the wound is cured
, measured in number of days. This is also determined by the classification
pedis.
Secondary outcome
Secondary outcome measure:
- New wound to the treated toe.
This is defined as a wound other than the existing wound at the time of the
intervention, as it may be in the same place as in any other place but in the
same toe.
Is determined by the classification Pedis.
- Caused infection of the treated toe
This is defined as: There must be at least one of the following clinical
symptoms: redness, local swelling or heat to the treated toe. This is measured
in temperature (fever), skin temperature, blood values **Leukocytes +
C-reactive protein (CRP) and also through the Pedis classification.
Fever: At temperature> 38.50 C (ear thermometer).
Skin temperature: Infection> 20C difference with the other foot (skin
thermometer).
Leukocytes> 10 E9 / L infection.
CRP> 10mg / L infection.
- Wound size of the existing wound.
This is defined as the extent of the wound and is measured in millimeters x
millimeters, with a wound centimeter measurer, and is also classified by the
pedis classification .
- Wound Classification
This is defined on the causes and characteristics of a diabetic foot ulcer and
is measured according to the classification pedis
- Complication lingering toe (grasping toe)
Background summary
The treatment that is now handled in the diabetic foot clinic in the Atrium MC
is mainly conservative and focused on relief through Orthopaedic Footwear (OS),
callus removal, foam, felt, orthosis or Total Contact Cast (TCC) (Van Schie,
2005). In contrast, in other countries and in several Dutch hospitals often
surgical intervention (Kearney, Hunt, & Lavery, 2010; Kim, 2008; Roukis, 2009;
Roukis & Damage, 2009; Van Schie, 2005) is used. There are several surgical
techniques that have been described, such as resection of PIP or DIP,
arthrodesis of the PIP joint or lengthening of the extensor tendon. A recently
described surgical technique is the subcutaneous flexor tenotomy, which means
the subcutaneous cleavage of the flexor digitorum longus. This is a
minimally-invasive procedure that is carried out with a "Admix needle" (page
6,7,18 protocol), and can be used for hammer toes and claw positions (Kearney,
et al, 2010). By cleaving this tendon, the toe backs into its anatomical
position allowing optimal pressure relief and the wound can heal. Moreover, the
chance of a new wound wil be equal to the probability of a wound in a toe in
anatomical position. It is known that the wound healing time without this
surgery is an average of 2 to 5 months (Diabetic Foot, 2006).
Research has shown that after the percutaneous flexor tenotomy 98.3% to 100% of
the wounds healed completely within a period of 40-52 days (Kearney, et al,
2010; Laborde, 2007, page 3-4 Protocol). The importance of the research is
therefore primarily to demonstrate that percutaneous flexor tenotomy is an
effective way to treat poorly healing ulcers in diabetic patients with
hammertoes. We want to measure this effect by determining the healing time,
percentage healed wounds and decrease in size of the wound.
-Diabetischevoet, R. (2006). Richtlijn Diabetische Voet. from
http://www.diabetesfederatie.nl/folder-preventie-in-praktijk/richtlijnen-en-advi
ezen/implementatieplan-richtlijnen-diabetes-mellitus/index.php?option=com_docman
&task=cat_view&gid=40&Itemid=99999999&mosmsg
-Kearney, T. P., Hunt, N. A., & Lavery, L. A. (2010). Safety and effectiveness
of flexor tenotomies to heal toe ulcers in persons with diabetes. Diabetes
research and clinical practice, 89(3), 224-226.
-Kim, J. (2008). Modified resection arthroplasty for infected non-healing
ulcers with toe deformity in diabetic patients. Foot & ankle international,
29(5), 493-497.
-Laborde, J. M. (2007). Neuropathic toe ulcers treated with toe flexor
tenotomies. Foot & ankle international/American Orthopaedic Foot and Ankle
Society [and] Swiss Foot and Ankle Society, 28(11), 1160.
-Roukis, T. S. (2009). A 1-piece shape-metal nitinol intramedullary internal
fixation device for arthrodesis of the proximal interphalangeal joint in
neuropathic patients with diabetes. Foot & Ankle Specialist, 2(3), 130.
- Roukis, T. S., & Schade, V. L. (2009). Percutaneous flexor tenotomy for
treatment of neuropathic toe ulceration secondary to toe contracture in persons
with diabetes: a systematic review. The journal of Foot and Ankle Surgery,
48(6), 684-689.
- Van Schie, C. (2005). A review of the biomechanics of the diabetic foot. The
international journal of lower extremity wounds, 4(3), 160.
Study objective
To demonstrate that percutaneous flexor tenotomy is an effective way to treat
poorly healing ulcers in diabetic patients with hammertoes. We want to measure
this effect by determining the healing time, percentage healed wounds and
decrease in size of the wound.
Study design
Quasi experimental
Intervention
Under local anesthesia, the flexor digitorum longus of the corresponding toe is
percutaneously cleaved using a small knife of about 2mm in width (Admix
non-coring needle). The wound that is made on the underside of the toe is
therefore limited to 2mm.
The surgery will be performed by a trained Nurse practitioner or assistant
physician at the outpatient surgery.
As said before use wil be made of an Admix needle , this is a needle with a
cutter at the end.
At the height of the spot a prick will be made with the Admix needle, where the
toe will be moved manually untill the flexor is cut, after which the needle is
removed.
Then, the wound will be treated with betadine gauze and a bandage. The patient
can immediately be discharged and will have to come for a checkup 1 week after
surgery. During the first 24 hours, the patient is not allowed to put weight on
the leg. The day after the operation, the bandage may be removed and the
prescribed anti-infection material can be put on the old existing wound and
fixated with a bandage
The next day the patient can put weight on the foot and walk normally, provided
the Pullman shoe is worn.
Study burden and risks
By cleaving the flexor digitorum longus, the toe regains its normal anatomical
stand. This may take several days to weeks. The effect of a normal position of
the toe on wound healing is expected to become noticeable after 2 weeks. The
chance that the wound, after pursuing optimal wound healing, is therefore
expected to be large. The risk of amputation will thereby decrease. The signs
that may indicate an infection during the study will be closely monitored and,
if necessary, blood will be pinned.
Some people experience the ability to no longer bend the toe at their own
desire as disturbing.
The intervention itself is minimally invasive and complications are not
expected.
H.Dunantstraat 5
Heerlen 6419PC
NL
H.Dunantstraat 5
Heerlen 6419PC
NL
Listed location countries
Age
Inclusion criteria
- Patients older than 18 years of age (female and male)
- Patients with hamertoe and existing wounds on the concerning toe.
- Wound exists longer than 3 months and is treated at the diabetic foot clinic
- Patients with diabetes mellitus and treated by the general practitioner or by the Internal medicine physician
- Osteomyelitis (patients with osteomyelitis on the toe due to a non-healing wound caused by a hammer toe, are also included). Osteomyelitis is diagnosed using radiographic photography ( an obvious cortical disruption can be seen here). This x-ray is requested by the diabetic foot clinic and belongs to the standard care (covered by regular health insurance).
Exclusion criteria
- Halluxpressure lower than 40mmHg, measured at the vascular laboratory in accordance with regular care
- Last new orthopedic footwear less than 26weeks old
- Antibiotic use 2 weeks prior to operation
- Antibiotic use for other indications than use for the affected foot, and 3 weeks after surgery
- Note: Amputation of another toe in the past is no reason for exclusion
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38898.096.12 |