|- candidate number||25642|
|- NTR Number||NTR6142|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-dec-2016|
|- Secondary IDs||61960 ABR-nummer|
|- Public Title||Total contact versus Total contact Softcast in treatment neuropathic plantar ulcers.|
|- Scientific Title||TCC versus TCS|
|- hypothesis||A TCS is comparable to TCC and an effective treatment in neuropathic forefoot ulcer,|
|- Healt Condition(s) or Problem(s) studied||Diabetic foot, Ulcers|
|- Inclusion criteria||age >18 years old, mental competence and understanding of the Duth language|
Diagnosis: Neuropathic ulcers without sign of ischemia, ability to walk more than 20 meters, wound depth tissue losts grade D1 and D2 according tot PEDIS I1 and I2
|- Exclusion criteria||patients with a Charcot deformity, excessive edema of the lower leg, immobility (<20 meters)|
an ankle brachial pressure index<0.9 and clinical signs of wound infection.(wound classification according to PEDIS Classification)
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||31-jan-2017|
|- planned closingdate||4-apr-2018|
|- Target number of participants||76|
|- Interventions||Total Contact Cast |
|- Primary outcome||Results of ulcer-healing equally well for TCS, as compared to TCC? When looking AT THE PERCENTAGE OF ULCER-HEALING AT 12 WEEKS FOLLOW UP.|
|- Secondary outcome||Time to wound healing|
validated Quality of life score.
|- Timepoints||patients visit the outpatient clinic weekly for a cast change and wound inspection by a wound nurse.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| B.P. Vierhout|
|- CONTACT for SCIENTIFIC QUERIES|| B.P. Vierhout|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief summary||A Total Contact Softcast (TCS) is a new alternative treatment for patients with a forefoot ulcer.
An increasing number of Hospitals in the Netherlands use a TCS or the Total Contact Cast (TCC):
the golden standard for off-loading. Patients have a better comfort in a TCS instead of a TCC,
resulting in an easier walking pattern. Cast technicians observe adequate healing of the wounds.
A comparison between both techniques was never made (to our knowledge). A TCS relieves
multiple possible causes prohibiting mobilization. It may shorten the treatment duration and
increase the quality of life.
The impact of excessive pressure on the sole of the foot in the pathogenesis of neuropathic
plantar ulcers, is well established. It is also known that complete relief of pressure from the
ulcerated area is the key to effective healing. A non-removable Total Contact Cast is the golden
standard for off-loading ulcers located at the forefoot or midfoot. Patients walk for weeks or
several months with a TCC: After 12 weeks resulting in 90% healing of the patientsí wounds.
This non-removable knee-high device, including ankle joint immobilization, reduces the activity
level with a potential risk of falls and knee or hip complaints due a provoked asymmetry in
walking. Early discontinuation because of inconvenience of the TCC was seen in 21% of the
patients. The use of a TCC is contraindicated, in patients with infection or critical ischemia.
A relative contraindication is found in elderly, patients with visual or equilibrium problems, and
patients with a contra lateral foot ulcer or varicose veins. Other reasons for discontinuation are
pressure points and joint problems in 7% of the patients. Also ankle stiffness and lower back pain
disturb the walking pattern.
In a Total Contact Softcast the ankle is wrapped in a semi-rigid stretch bandage allowing
movement of the ankle joint. The sole is constructed of a rigid cast. This allows a normal walking
pattern combined with off-loading of pressure points of the wounds. The World Health
Organization (WHO) defines disability as one of the problems an individual may experience in
functioning. This may be positively influenced by the accomplishment of a physically active
lifestyle with a semi-rigid cast: A TCS.|
|- Main changes (audit trail)|
|- RECORD||8-dec-2016 - 17-mei-2017|