The Cluffy Wedge is the trademarked name for a commercially available pad that is placed under the hallux that was developed to treat functional hallux limitus. It was originally designed and developed by Dr James Clough, DPM and the trademark, first granted in 2003 is owned by his company, Cluffy LLC, based in Polson, Montana. The Cluffy Wedge was marketed for a period of time as the P4 Wedge.
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The polyurethane pad comes in several sizes to match the size of the hallux; it is 6mm thick at the distal end for the larger size. The Cluffy Wedge can be used on its own as a stand-alone pad in the shoe or it could be adhered to an extension on the anterior of a foot orthotic. It is commercially available to the public via Amazon.com and the Cluffy LLC website. A number of retailers also stocked the product and were given training via YouTube videos. Some podiatry product wholesalers did originally offer the product, but none appear to carry it now.
Some commercial foot orthotic laboratories did originally offer the Cluffy Wedge as a prescription option on their foot orthotics, but the uptake did not warrant the continuation of the product. Many labs do now offer a prescription option for ‘padding under the hallux to hold it slightly dorsiflexed‘ (or similar wording) that they manufacture themselves from several different material options to have the same effect as what a Cluffy Wedge would.
Promotional video for the Cluffy Wedge:
While the Cluffy Wedge and similarly designed foot orthotic options do appear to have some clinical use on the theoretical construct of functional hallux limitus, it will also have an effect on the function of the windlass mechanism in the foot as holding the hallux dorsiflexed will hypothetically place increased load on the windlass mechanism earlier in the stance phase during gait, leading to the concept of ‘preloading the hallux’. This is hypothetically useful when there is what has been considered as a delayed onset to the windlass mechanism; however, it is not known if this is potentially harmful in those who could be considered to have a normally functioning windlass mechanism that is not delayed.
The mechanism of action of the Cluffy Wedge is most likely via its effect on the windlass mechanism or its effect on the construct of functional hallux limitus by holding the first metatarsophalangeal joint in a slightly dorsiflexed position. The promotional materials frequently talk about ‘balancing’ the load on the forefoot:
“Unlocking the big toe joint can be your first and most critical step toward normal walking and physical harmony, by restoring your foot to healthy and correct function. As normal function is achieved, pressure on the ball of the foot is balanced. The entire foot and leg are brought into alignment and you are restored to a firm, stable foundation. This not only reduces your injury potential, but also enhances foot performance.”
Clough (2009) described the mechanism of action as:
Elevating the hallux slightly allows the first metatarsal to bear weight as dorsiflexion occurs and therefore allows appropriate and physiological off weighting of the lesser metatarsals. As the first metatarsal bears more weight, re-supination of the rearfoot can occur in a normal fashion. Fredericksen noted in his article that heel pressures were decreased in midstance and that there was a faster progression of the foot into propulsion. Forefoot pressures showed a tendency towards first metatarsal weight bearing and less weight on metatarsals 2, 3 and 4, and a medialization of the trajectory of force through the first ray.
It is unknown if there are side effects if the hypothetical effects of windlass mechanism function is normal and the wedge could potentially interfere with that normal function. It also has unknown effects if used when functional hallux limitus is not present and if this could be problematic. Another potential side effect with the use of the Cluffy Wedge is the dorsal jamming to the toenail on the underside the toebox of the shoe due to the thickness of the padding. The use of the design feature is also predicated on there being a range of dorsiflexion at the first metatarsophalangeal joint available, so a hallux rigidus would be a contraindication to its use.
There are other design features in foot orthotics that can be used to get a similar clinical affect such at the Kinetic Wedge, first ray cut out and the reverse Morton’s extension.
Two videos of anecdotes of the effect of a Cluffy Wedge:
Treadmill study on the effect of the Cluffy Wedge:
Cluffy Wedge effect on plantar foot pressures/dynamic study:
Research using the Cluffy Wedge:
There are no peer-reviewed clinical trials on the use of the Cluffy Wedge. There have been some studies and publications on it:
- Clough (2005) – this was not a research study, however this review on functional hallux limitus is when the Cluffy Wedge was first described.
- Morales (2019) is an abstract from a thesis in Español which using Google translate reported:
Functional Hallux Limitus is a common pathology in our consultations that influences the mobility of the 1st art. MTF and can be treated in different ways. The Cluffy Wedge is an orthotic element indicated, among others, to treat Functional Hallux Limitus. It consists of a 6mm thick wedge placed under the Hallux, which has the purpose of dorsiflexing the first toe and plantarflexing the 1st CMTT, achieving a functional position of the 1st art. MTF, with the aim of normalizing the load distribution in the forefoot and improving propulsion. The hypothesis is that after the placement of the Cluffy Wedge an increase in the load is achieved under the 1st art. MTF and a reduction of the same in metatarsal heads from 2º-5º. A study has been carried out where, using the F-Scan system, the influence of the Cluffy Wedge in the 1st art area is analyzed. MTF, central radii and Hallux, in a sample comprised of 6 participants. The results obtained have been compared with the influence of the kinetic wedge in the 1st art MTF and Hallux area, since both elements treat the same pathology and with a study on the Cluffy Wedge carried out by its inventor. The evaluation of the results does not provide clear information on how the Cluffy Wedge affects the pressures in 1st art. MTF, but it does show a clear decrease in the load in central radii, in addition to an increase in the same in the Hallux area.
- Klepec et al (2017) was a conference poster, reporting that:
The aim of this study was to determine if placing the big toe in a dorsaflexed position affects the average vertical jump height of volleyball players and whether the grade of functional hallux limitus (FHL) limits its effectiveness. A polyurethane wedge (Cluffy Wedge) was placed under the big toe of 30 volleyball athletes. Two sets of three vertical test jumps were completed for each individual and t-tests of average jump heights showed no difference with or without the Cluffy Wedge. The subjects were then tested for FHL. Results showed slight significance in average jump heights for FHL grade 0 (p= 0.1401), while showing no significance in FHL grade 1 (p= 0.6949) and 2 (p= 0.9045). In conclusion, using a Cluffy Wedge to induce dorsiflexion of the big toe did not affect the average jump height of volleyball athletes and the FHL grade had no influence.
- There was some data from Schut (2011) that appeared on a website that no longer is live for the ‘The Cluffy Institute’, that showed faster sprint times in most of those using the Cluffy Wedge over 10 and 40yd sprints. The study was not peer-reviewed and has not been published in full. There is the Wayback archive of the data from cluffyinstitute.com and a discussion of the study at Podiatry Arena. No information was available on the details of the study such as blinding of the participants.
Commentary:
- The Cluffy Wedge as a foot orthotic design feature appears to be useful when indicated such as for a functional hallux limitus or a delayed onset to the windlass mechanism
- There is a lack of clinical trials on its use.
- On Amazon.com, there are a number of negative reviews from consumers. It could be speculated that they perhaps used the product when it was not indicated.
External Links:
Cluffy LLC
Pre-loading the hallux (Podiatry Arena)
Cluffy Wedge (Podiatry Arena)
Cluffy wedge (Podiatry Arena)
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