Flexor tendon tenotomy treatment of the diabetic foot: a multicenter randomized controlled trial.
Open accessAbstract
OBJECTIVE: The aim of this study was to evaluate the effects of needle flexor tendon tenotomy treatment of the diabetic hammertoe deformity. RESEARCH DESIGN AND METHODS: A multicenter randomized controlled trial of individuals with diabetes and ulcers or impending ulcers associated with hammertoes was performed between 1 November 2019 and 31 March 2021. Participants were stratified by the presence of ulcers or impending ulcers. Participants were randomly assigned to tenotomy and standard nonsurgical treatment or to standard nonsurgical treatment alone. Primary outcomes were time to ulcer healing and progression from impending ulcer to active ulcer. RESULTS: Of 224 screened participants with diabetes, 95 (59.0% men) were included. The mean follow-up was 291 ± 70 days, 28 (29.5%) had type 1 diabetes, mean diabetes (presented with 25-75% quartile) duration was 20 (13-26) years, and mean age was 67.7 ± 9.8 years. Of the included participants, 16 had ulcers, of whom 8 were randomly assigned to intervention. Of the remaining 79 with impending ulcers, 39 were randomly assigned to intervention. For participants with ulcers, healing rates favored tenotomy (100% vs. 37.5%, P = 0.026) as did time to ulcer healing (P = 0.04). For those with impending ulcers, incidence of progression to an active ulcer was lower (1 vs. 7, P = 0.028) and the number of ulcer-free days higher (P = 0.043) in the tenotomy group. No serious adverse events were recorded. CONCLUSIONS: This randomized study showed that the simple procedure of needle flexor tendon tenotomy was effective and safe when treating and preventing ulcers associated with the diabetic hammertoe deformity.
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Off-loading repetitive mechanical stress on the foot, consisting of reducing weight bearing on the ulcer, reduces pressure over the wound by spreading force over a larger unit area, thus providing an environment for healing.
“Off-loading repetitive mechanical stress on the foot, consisting of reducing weight bearing on the ulcer, is an important aspect of treatment and reduces pressure over the wound by spreading force over a larger unit area, thus providing an environment for healing.55”
From Diabetic Foot Ulcers (2023) · cites this paper as [55]
The Offloading Devices section describes offloading footwear as part of standard treatment, and the Conclusions say pressure can be relieved from a toe. The Ulcer Group results report better healing with tenotomy. The paper does not explain offloading as spreading force over a larger area or establish that mechanism for healing. (LLM, conf=0.86)
Experimental — accuracy not yet measuredKnee-high nonremovable offloading device promotes better healing compared with removable devices (relative risk, 1.24; 95% CI, 1.09-1.41).
“promotes better healing compared with removable devices (relative risk, 1.24; 95% CI, 1.09-1.41[absolute rates not provided]).”
From Diabetic Foot Ulcers (2023) · cites this paper as [55]
The Offloading Devices section says participants were offered rocker-bottom sandals with custom insoles, but it does not compare knee-high nonremovable devices with removable devices. The Ulcer Group results compare tenotomy with control, not those device types. Searches for the device comparison and the reported relative risk found no supporting passage in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredKnee-high nonremovable offloading device reduces pressure at the ulcer by 80%-90% compared with a standard shoe.
“Knee-high nonremovable offloading device 51 Total contact cast or knee-high walker rendered nonremovable Reduces pressure at the ulcer by 80%-90% compared with a standard shoe 55”
From Diabetic Foot Ulcers (2023) · cites this paper as [55]
The Offloading Devices section describes rocker-bottom sandals and custom insoles, but does not discuss knee-high nonremovable devices or compare ulcer pressure with a standard shoe. Searches for total contact casts, knee-high walkers, and an 80%–90% pressure reduction found no passage supporting the claim. (LLM, conf=0.76)
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References 35 · Cited by 29
- Authors
- Askø Andersen, J., Rasmussen, A., Engberg, S., Bencke, J., Frimodt-Møller, M., Kirketerp-Møller, K., & Rossing, P.
- Affiliations
- 1Steno Diabetes Center Copenhagen, Herlev, Denmark
- Steno Diabetes Center Copenhagen (DK)
- Novo Nordisk (Denmark) (DK)
- Amager Hospital (DK)
- University of Copenhagen (DK)
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2022-09-24
- Volume
- 45
- Issue
- 11
- Pages
- 2492-2500
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W4297186277
- Cited by
- 29
- References
- 35
- Citations by year
- 2026: 7 · 2025: 8 · 2024: 6 · 2023: 8
- FWCI
- 4.09
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
- Funders
- Eli Lilly and Company
- AstraZeneca
- Sanofi
- Gilead Sciences
- Jascha Fonden
- Steno Diabetes Center Copenhagen
- European Foundation for the Study of Diabetes
- Coloplast
- Novo Nordisk
- Astellas Pharma
- Hvidovre Hospital
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Foot and Ankle Surgery
- Health Sciences › Medicine › Dermatology › Skin Diseases and Diabetes
- Keywords
- diabetic foot, diabetic foot ulcer, ulcer healing, ulcer prevention, conservative treatment
- MeSH terms
- Aged, Diabetes Mellitus, Female, Humans, Male, Middle Aged, Tendons, Wound Healing, Incidence, Diabetic Foot, Tenotomy
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