An interventional study of Botulinum toxin type A and sodium chloride in Equinus Contracture, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if botulinum toxin type A (Botox) injections, at the time of surgery for pilon fractures, will improve ankle range-of-motion and functionality.
To determine if the use of Botulinum toxin A intramuscular injections of the gastrocsoleus complex in patients with operatively treated tibial plafond fractures will result in:
10 studies on the registry are indexed under Equinus Deformity; 3 are open to participants now.
Browse Equinus Deformity studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(Non-definitive, interval procedures such as repeat irrigation and debridement and fibular fixation are allowed.)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Botox: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U
Drug: Botulinum toxin type A
Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U
Drug: sodium chloride
At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U
Also known as: Botox
At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U
Also known as: Normal Saline
Ankle Dorsiflexion of Injured Extremity
The difference in ankle dorsiflexion between the injured and un-injured ankles as measured with goniometer 6 month from surgery.
Time frame: 6 month follow-up visit
Short Form-36 (SF-36)Health Related Quality of Life
The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best)
Time frame: 6 month follow-up visit
Short Form-36 (SF-36) Health Related Quality of Life
The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best)
Time frame: 12 month follow-up visits
Ankle Pain at 6 Month
Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame: 6 month follow-up visit
Ankle Pain at 12 Month
Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame: 12 month follow-up visit
Functional Status of the Ankle at 6 Month
The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
Time frame: 6 month follow-up visit
Functional Status of the Ankle at 12 Month
The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. A higher score represents a higher level of physical function.
Time frame: 12 month follow-up visit
| Milestone | Botox | Placebo |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 4 |
| Not completed | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
The difference in ankle dorsiflexion between the injured and un-injured ankles as measured with goniometer 6 month from surgery.
| degrees | Botox | Placebo |
|---|---|---|
| Ankle Dorsiflexion of Injured Extremity | -3.8 (-12 to 5) | 11.8 (-3 to 40) |
The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best)
| units on a scale | Botox | Placebo |
|---|---|---|
| SF-36 Physical Functioning) | 30.0 ± 24.5 | 55.0 ± 16.8 |
| SF-36 Role functioning/physical | 0 ± 0 | 0 ± 0 |
| SF-36 General health | 65.0 ± 21.6 | 68.8 ± 18.9 |
The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best)
| units on a scale | Botox | Placebo |
|---|---|---|
| SF-36 Physical Functioning) | 45.0 ± 36.1 | 70.0 ± 13.2 |
| SF-36 Role functioning/physical | 58.3 ± 52.0 | 33.3 ± 38.2 |
| SF-36 General health | 63.3 ± 37.5 | 75.0 ± 26.5 |
Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
| units on a scale | Botox | Placebo |
|---|---|---|
| Pain Severity (BPI) | 3.38 ± 1.9 | 2.94 ± 1.2 |
| Pain Interference (BPI) | 3.4 ± 2.4 | 1.7 ± 2.6 |
Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
| units on a scale | Botox | Placebo |
|---|---|---|
| Pain Severity (BPI) | 2.92 ± 2.5 | 3.17 ± 1.4 |
| Pain Interference (BPI) | 4.1 ± 3.5 | 1.0 ± 1.0 |
The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
| units on a scale | Botox | Placebo |
|---|---|---|
| Functional Status of the Ankle at 6 Month | 32.4 ± 19.0 | 65.2 ± 20.7 |
The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. A higher score represents a higher level of physical function.
| units on a scale | Botox | Placebo |
|---|---|---|
| Functional Status of the Ankle at 12 Month | 63.1 ± 12.5 | 70.2 ± 16.9 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botox | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Placebo | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Botulinum Toxin Type A | 0.9% Sodium Chloride | Total |
|---|---|---|---|
| Mean | 45.2 ± 8.9 | 42.0 ± 11.0 | 43.6 ± 9.6 |
| Sex: Female, Male(Participants) | Botulinum Toxin Type A | 0.9% Sodium Chloride | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 5 | 4 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
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